Showing posts from August, 2009

Warnex introduces test for influenza A H1N1 virus associated with resistance to Tamiflu

Warnex Inc. announced that its Medical Laboratories division has launched a test for the detection of a mutation of the pandemic influenza A H1N1 virus, which is associated with resistance to Tamiflu, a drug used for the treatment and prevention of the flu. The test specifically detects the H275Y mutation of the neuraminidase gene, which has been shown to cause resistance to Tamiflu.

Durect to supply two excipients to King Pharma for Remoxy manufacturing

Durect Corporation has signed an exclusive long term excipient supply agreement with respect to Remoxy with King Pharmaceuticals, Inc. This agreement stipulates the terms and conditions under which Durect will supply to King, based on Durect's manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of Remoxy. Remoxy, based on Durect's Oradur technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for Remoxy was accepted by the FDA and was granted Priority Review. In December 2008, the FDA issued a Complete Response Letter related to Remoxy. In July 2009, King Pharmaceuticals met with the FDA to discuss the Complete Response Letter and King Pharmaceuticals has stated that it anticipates that the resubmission of the NDA could occur mid-year 2010.

Several drugs banned in US, Europe freely marketed in India

Several drugs, banned for their serious side effects in developed nations like US, Canada and European Union, are freely available in the country. Though the list of such drugs is long, the latest among them is a combination drug of flupenthixol and melitracen, sold under the brand name of Deanxit. The product has been banned in the above countries for its serious adverse drug reactions. According to sources, though melitracen, one of the two ingredients in Deanxit is not approved in India, the Drug Controller General of India (DCGI) is learnt to have cleared the combination reportedly without mandatory clinical trials.   The sources said that the drug is being aggressively promoted for a wide range of known and unknown disorders such as psychogenic depression, depressive neuroses, masked depression, menopausal depression, dysphoria in alcoholics and drug addicts etc without mandatory clearance from the DCGI.  

Hisamitsu Pharmaceutical Completes Acquisition of Noven Pharmaceuticals

Hisamitsu Pharmaceutical, a Japanese developer and marketer of prescription and over-the-counter pharmaceutical products, and Hisamitsu US have completed the acquisition of Noven Pharmaceuticals, a US-based specialty pharmaceutical company, pursuant to a short form merger of Northstar Merger Sub, a wholly owned subsidiary of Hisamitsu US, with and into Noven. Pursuant to the agreement and plan of merger among the companies, at the effective time of the merger all remaining outstanding shares of Noven's common stock, other than those held by stockholders who properly perfect appraisal rights under Delaware law, were converted into the right to receive $16.50 per share in cash. As a result of the transaction, Noven has become a wholly owned subsidiary of Hisamitsu US. Hisamitsu expects Noven to continue as a stand alone business unit under the Noven name, operating at its current locations in Miami and New York, and with its existing workforce.  

ImmuneRegen Signs MTA Agreement With Archimedes Development

ImmuneRegen BioSciences, a wholly owned subsidiary of IR BioSciences Holdings, has announced the execution of a material transfer agreement or MTA with a UK-based specialty pharmaceutical company Archimedes Development, an initial step to enable the companies to investigate possible synergies between their technology platforms. Hal Siegel, chief scientific officer of ImmuneRegen, said: "Multiple studies in different model systems have shown that Homspera can protect experimental animals and enhance their immune responses to vaccine-delivered antigens, DNA-encoded viral proteins or tumor antigens, as well as provide protection in our anthrax and influenza therapeutic studies. In addition to these findings in animals where Homspera has been administered intranasally as a liquid, inhaled or injected under the skin, we have shown in laboratory studies that Homspera can stimulate blood-forming stem cells to produce more white blood cell precursors, particularly those for granuloc

Nutra Pharma Announces Licensing Agreement With XenaCare Holdings to Market and Distribute Cobroxin

Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has successfully completed a licensing agreement that grants XenaCare Holdings (OTCBB:XCHO) ongoing exclusive United States marketing and distribution rights for Cobroxin in return for meeting specific minimum performance requirements. Cobroxin is the first OTC pain reliever clinically proven to treat Stage 2 (moderate to severe) chronic pain. The drug, which was developed by Nutra Pharma's wholly-owned drug discovery subsidiary, ReceptoPharm, will be available as an oral spray (NDC47219-102-52) for treating lower back pain, migraines, neck aches, shoulder pain, cramps and neuralgia and as a topical gel (NDC47219-104-50) for treating repetitive stress, arthritis, and joint pain.  

APP Pharmaceuticals Receives Approval for Penicillin G Potassium for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ), announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market penicillin G potassium for Injection, USP, in two dosage strengths. Penicillin G is therapeutically equivalent to the reference drug PfizerPen G, which is marketed by the innovator Pfizer, Inc. APP will package Penicillin G in 5 million and 20 million unit single dose vials. APP's Penicillin G is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States were approximately $16.4 million1.  

Elorac, Inc. Announces Launch of Novel, Steroid-Free, Prescription Cream for Psoriasis

Now patients with mild to moderate plaque psoriasis have a new topical treatment option available by prescription. Zithranol-RR (anthralin rapid release microcrystalline encapsulated cream, 1.2%), is an innovative topical therapy for plaque psoriasis according to Elorac, Inc., a privately held emerging dermatology company. Zithranol-RR provides an advanced delivery system for anthralin achieving long remission times with no long-term side effects in a steroid-free, silky cream. While there is no cure for psoriasis, treatment can clear psoriatic skin for periods of time. Zithranol-RR contains the active ingredient anthralin which has been shown to clear psoriasis and keep it in remission for long periods of time with only once-a-day application.  

Dyax announces developments in licensing & funded research programme

Dyax Corp announced successful advancement into phase-1 clinical trials of two candidates identified using Dyax's proprietary phage display technology by licensees of the company's Licensing and Funded Research Programme (LFRP). LFRP licensee ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, recently announced it initiated clinical development for oncology candidate IMC-EB10, ImClone's anti-FLT3 antibody, for the treatment of acute myelogenous leukaemia. Dyax received a milestone payment of $1.5 million for commencement of the phase-1 trial which was initiated in the second quarter of 2009. Additionally, Dyax licensee MedImmune, the biologics business of AstraZeneca, announced it has advanced MEDI-547, an antibody-drug conjugate targeting EphA2 receptor for oncology indications. Dyax will receive an undisclosed milestone payment for the phase-1 trial initiation. Dyax is eligible to receive additional future milestones associated with the development o

NIH issues guidelines for prevention and treatment of secondary infections

New guidelines to assist health care workers in preventing and treating the secondary infections that can afflict US children exposed to, or infected with, HIV, were published by the National Institutes of Health and the Centers for Disease Control and Prevention.   The new guidelines provide a reference manual for the treatment of these secondary infections, describing warning signs of potentially hazardous interactions between drugs used to treat HIV and its secondary infections, current standards for treating the inflammation accompanying the immune system recovery made possible by new anti-HIV drugs, as well as when to discontinue preventative treatment no longer needed after the immune system has recovered.

Modicare launches SteriClean - a powerful disinfectant to control growth of swine flu virus

To control and inactivate the H1N1 or swine flu virus, Modicare, a leading direct selling company has introduced Modicare SteriClean disinfectant cleaner. The powerful biodegradable disinfectant containing 12 per cent benzalkonium chloride, an effective fungicide, germicide and virucide is ideal for disinfecting and sanitizing households, hospitals, clinics, hotels, restaurants, schools and colleges.   Available in 250 ml and 1000 ml packs priced at Rs 64 and Rs 218 respectively, SteriClean provides disinfections against a wide spectrum of harmful bacteria, fungi and viruses. SteriClean can also be used to sanitize floors, walls, bed frames, chairs, tables, doors, doorknobs, telephone instruments and food contact surfaces. In addition, it can also be sprayed or used for mopping and wiping.  

NIMHANS gets Rs 30 lakh DBT funding for research on metabolic abnormalities

National Institute of Mental Health and Neuro Sciences (NIMHANS) has received a Department of biotechnology funding of Rs 30 lakh for a research effort in the area of metabolic abnormalities leading to psychiatric disorders. The research which spans for three years will end in 2011. The department of psychiatry which has set up a dedicated Metabolic Clinic and Schizophrenia Clinic are now examining patients on the hormone abnormalities and mental disorders which is one-of-the-first initiatives in contemporary international psychiatry.   The key objective of this research is to help synthesize existing clinical assessments and help translate it into meaningful approach to take care of psychiatric patients with metabolic conditions like obesity or hyperglycaemia. Under the research programme, about 60 schizophrenia patients and 40 healthy subjects for comparative purposes have been examined till now said Dr G Venkatasubramanian, assistant professor of psychiatry, consultant, Metabo

Abbott, Pfizer to develop molecular diagnostic test to screen NSCLC patients

Abbott has entered into an agreement with Pfizer Inc to develop a molecular diagnostic test intended to screen non-small cell lung cancer (NSCLC) tumours for the presence of gene rearrangements. Pfizer has developed a novel investigational agent that selectively targets cancer-causing genes implicated in the progress of many cancers. To be eligible to receive Pfizer's oral therapy, a particular genetic translocation (rearrangement) known to be found in NSCLC tumours and a wide variety of other cancers, but not in normal cells, must be present. Under terms of the agreement, Abbott will develop a companion diagnostic test that will determine a patient's genetic status and will be used in patient selection for future clinical trials of PF-02341066.

Pharma market hit by monsoon shortfall, growth at 8.9% in July 09: ORG IMS

The value growth in Indian pharma retail market has decreased in the month of July to 8.9 per cent, as compared to a growth of 18.3 per cent in the pervious month, owing to the monsoon shortfall in most parts of the country, according to the monthly Indian Pharmaceutical Market (IPM) report of ORG IMS. As per the secondary sales audit report of the market surveillance firm, the slight dip in value growth appears to be the likely cause for the downfall, with categories like infectives, cough and cold preparations, anti-diarrhoeals, anti-asthmatics, anti-inflammatory and anti-rheumatics posting low to declining growths. Normally, the market for these products shows a seasonal spurt in the month of July. The sale of pharma products is reported at Rs 3,456.41 crore in the month of July, this year. "After growing at a blistering 18.3 per cent in the previous month (Jun'09), the pharmaceutical retail market was relatively subdued in July 09, posting a modest growth of 8.9 per

Restricting Innovation is Hurting Indian Patients: USIBC's Coalition for Healthy India

India Business Council supported ‘Coalition for Healthy India’ released the findings of its report on “The Value of Incremental Pharmaceutical Innovation: Benefits for Indian Patients and Indian Business”. The report highlights and substantiates the impact of restrictive policies in India, with respect to medical and pharmaceutical innovation. The report adds a patient-centric perspective to the public discourse on IPR and drug patents and points out the positive impact that incremental innovation can have on patient care in India.   The CHI report notes that in the early 1990’s in India, pharmaceutical R&D as a percentage of sales jumped from 0.4% to as much as 4.8% by 2004. By 2006, after India began to allow patents on pharmaceutical products, India’s three largest pharmaceutical firms – Dr. Reddy’s, Sun Pharmaceuticals, and Ranbaxy – were investing almost 12-18% of their annual sales revenue in R&D. That’s on par with the leading global innovator firms.

Unichem Lab gets US FDA nod for clonidine HCl tabs

Unichem Laboratories, a Mumbai based Rs 725 crore plus pharma major has received US FDA approval for clonidine hydrochloride tablets. These tablets are a low dose potent and popular molecule in the anti-hypertensive category. The company is commencing marketing of this product from its Goa plant. The API ingredient i.e. clonidine hydrochloride used for this ANDA will also made in house at Roha plant.   Clonidine hydrochloride tablets USP 0.1 mg, 0.2 mg and 0.3 mg are therapeutically equivalent to Catapres tablets from Boehringer Ingelheim. This formulation has annual sales of approximately USD 334 million in the US.  

Aurobindo gets US & Swiss nod for two products

Aurobindo Pharma has received US FDA's final approval for Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg. Similarly, Swissmedic, Government of Switzerland has approved the license of Cefepime APL for Injection 1g and 2g. Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg (base) are generic equivalent to Cleocin Hydrochloride capsules 150mg and 300 mg of Pharmacia and Upjohn Company. Clindamycin Hydrochloride is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and falls under the anti-infective therapeutic segment. The product has a market size of approximately US$ 55 million for the twelve months ending March 2009, according to Newport. The product will be launched shortly. Aurobindo now has a total of 101 ANDA approvals (73 final approvals and 28 tentative approvals) from US FDA.  

US FDA warns Cambrex on API facility in Milan, Italy

Cambrex Corporation has received a warning letter from the US Food and Drug Administration (FDA) relating to an inspection of the company's generic active pharmaceutical ingredient (API) manufacturing facility located in Milan, Italy in March 2009. The observations noted in the warning letter are primarily related to the collection and maintenance of certain laboratory data. The company has already addressed a number of observations following the inspection and is fully committed to working with the FDA to resolve all of the outstanding issues expeditiously. While the warning letter indicated that until the company demonstrates that the observations have been corrected, the FDA may withhold approval of new applications or supplements listing the Milan, Italy facility as the API manufacturer, and may deny entry into the US of products manufactured at the site, the company anticipates satisfactorily responding to the letter within the time period prescribed by the FDA and correct

Depts of health, pharma begin consultation to introduce quality mark for generic drugs

Departments of Health and Pharmaceuticals have launched a process to introduce quality mark for the generic drugs by starting consultation with the stakeholders on the proposal. The industry, however, does not appear to be very happy with the move. A jointly held meeting by both the departments recently saw the leading pharma associations raising apprehensions about the proposal. The associations felt that it would not make much difference and cannot bring in any desired goal of further improving the quality of drugs in the country. Leaders of different associations attended the meeting, called by the pharma department. As the first step, the departments are planning to introduce a logo of quality for those drugs under price control and produced by GMP compliant units. Later, it would cover the entire spectrum of generic drugs in the country. The logo, on the lines of ISI mark or Agmark for other goods, would help the consumers to distinguish between quality and sub-standard drug

APP Pharma gets US FDA nod to market penicillin G potassium injection USP

APP Pharmaceuticals, Inc, a wholly-owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc, has received approval from the US Food and Drug Administration (FDA) to market penicillin G potassium for injection, USP, in two dosage strengths. Penicillin G is therapeutically equivalent to the reference drug PfizerPen G, which is marketed by the innovator Pfizer, Inc. APP will package penicillin G in 5 million and 20 million unit single dose vials. APP's Penicillin G is AP-rated, bar-coded and latex-free. According to IMS data, 2008 sales of this product in the United States were approximately $16.4 million1.

Endo Pharmaceuticals to Partner With ProStrakan to Commercialize FORTESTA(TM) in the U.S.

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it has signed an agreement with U.K.-based ProStrakan Group plc (LSE: PSK) for the exclusive right to commercialize FORTESTA(TM) (testosterone gel) 2 percent in the United States. FORTESTA, a patented 2 percent testosterone transdermal gel for testosterone replacement therapy in male hypogonadism, utilizes a metered dose delivery system designed to permit accurate dose adjustment to individual patient requirements. This product is in registration in the U.S., where the Food and Drug Administration (FDA) is currently reviewing ProStrakan's New Drug Application submission. Under the terms of the agreement, Endo Pharmaceuticals has agreed to make an upfront payment to ProStrakan of $10 million, with the potential for up to $40 million more in milestone payments by the end of 2010 for regulatory approval and the achievement of certain commercial milestones. Endo Pharmaceuticals has also agreed to pay ProStrakan an additiona

Bill & Melinda Foundation inks pact with NACO to check spread of HIV/AIDS in India

The Bill & Melinda Gates Foundation has inked a Memorandum of Cooperation with the National AIDS Control Organization (NACO) to reaffirm its mutual commitment to address the spread of HIV/AIDS in India. This will be done through the implementation, with NACO, under the Avahan programmes.   Avahan, launched in 2003 by the Gates Foundation provides funding and support to targeted HIV prevention programmes in six Indian states and along the national trucking routes.

Nanotherapeutics gets $30.9 mn NIAID contract to develop inhaled antiviral for prophylaxis & treatment of smallpox

Nanotherapeutics, Inc, has been awarded a $30.9 million, five-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version of the injectable antiviral drug, cidofovir, for non-invasive, post-exposure prophylaxis and treatment of the Category A bioterrorism agent smallpox (Variola major).  

Shire enters research collaboration with Santaris Pharma on LNA drug platform

Shire plc, the global specialty biopharmaceutical company, has entered into a research-based collaboration with Santaris Pharma A/S, a leading player in RNA-based therapeutics, to develop its proprietary Locked Nucleic Acid (LNA) technology in a range of rare diseases, thereby enabling Shire to build on its already strong competitive position for its Human Genetic Therapies (HGT) business. LNA technology has the benefit of a very quick validated target to proof of concept turnaround, thereby increasing the speed and lowering the cost of development. Currently, Shire HGT has a unique and successful platform producing human cell derived enzyme replacement therapies (ERTs) for a wide range of rare human genetic disorders.

Milestone Scientific may get US patent for C-CLAD systems

Milestone Scientific Inc, the recognized leader in advanced injection technologies, announced that the United States Patent and Trademark Office has issued a Notice of Allowance for Milestone's US patent application directed to the use of its disposable hand piece for fluid administration. Milestone's proprietary, award-winning hand piece is an instrument currently utilized in conjunction with the Company's commercially available Computer-Controlled Local Anaesthetic Delivery (C-CLAD) systems, including the STA Single Tooth Anaesthesia System, CompuDent and CompuMed.  

NIPER to set up office in Delhi for better coordination with DoP, other institutes

National Institute of Pharmaceutical Education and Research (NIPER), Mohali, which is coordinating different activities of all NIPERs as the lead institute, is planning to set up an office in New Delhi for better coordination with the concerned ministries and the Pharmaceutical Department and thereby channelising more benefits to the industry. The proposal for the same, among other things, will be considered for approval by the next meeting of the Board of Governors, taking place in Delhi on August 29, it is learnt.   With the setting up of the six more NIPERs at Hyderabad, Ahmedabad, Hazipur, Kolkata, Guwahati and Rae Barelli, there is an increase in academic and administrative activities such as compilation of reports by the co-ordinators of new NIPERs, to monitor the activities, holding joint meetings etc. At present, these activities are being coordinated by the NIPER, S.A.S. Nagar. An office in Delhi is expected to facilitate these activities.  

Fortis Healthcare to acquire 10 hospitals from Wockhardt for Rs 909 cr

Fortis Healthcare, a network of 28 hospitals with the capacity to increase inpatient beds to 3,300 beds, has decided to acquire eight operating hospitals and two hospital projects under construction from Wockhardt Hospitals for a total consideration of Rs 909 crore. The business transfer is expected to be completed by end of December 2009 upon the fulfilment of agreed conditions. The acquisition will enhance Fortis footprint in Southern, Western and Eastern India, thereby strengthening the Fiortis brand as one of the leading healthcare service provider in the country.   The 10 hospitals are spread across metros in three states (two in Mumbai, five in Bengaluru, and three in Kolkata) and will provide Fortis a pan India presence consistent with its stated strategy. This acquisition will augment the bed capacity by 1902 beds (including 534 beds in two Greenfield projects). With the acquisition, the aggregate bed capacity of the Fortis Network shall stand at 5180 beds spread over 38

Central agency for buying, distributing drugs for all govt depts, institutions mooted

The Centre is planning to set up a central procurement agency for buying and distributing medicines to all medical institutions under the government departments, with a view to bring in more transparency in such dealings. A cabinet note has already been prepared in this regard by the ministry of health and has been sent to all concerned ministries and departments for comments and inputs. The note will be submitted to the cabinet once the feedbacks come from these departments, it is learnt. According to the proposal, a central agency called Medical Services Corporation will be set up to procure and distribute drugs and other medical equipments to all institutions coming under different departments like health and railways, besides those coming under the State governments. "Transparency, equitability and competitiveness will be the parameters in the procurement policy being planned by the ministry," according to a senior official in the ministry.

Wockhardt Hospitals to re-pay Rs 500 cr debt from disinvestment

Wockhardt Hospitals, which is divesting its 8 operating hospital and two on going projects to Fortis Healthcare Ltd for a consideration of Rs 909 crore, is planning to reduce its debt burden by Rs 500 crore and investing remaining funds in new hospitals. The company is setting up new hospital in Juhu, South Mumbai in next 12 to 15 months. Further it is planning to set up new hospitals in Madhya Pradesh, Uttar Pradesh and Bihar.   By retaining seven of its super speciality hospitals in Rajkot, Surat, Nasik, Nagpur and Hyderabad, Wockhardt Hospitals has a strong presence in the Western part of the country. In addition to these, it has 3 community hospitals in Bhavnagar, Goa and Vashi in Mumbai.  

Ranbaxy gets US FDA nod for glycopyrrolate tabs to treat peptic ulcer

Ranbaxy Laboratories Limited (RLL), has received approval from the US Food and Drug Administration (US FDA) to manufacture and market glycopyrrolate tablets USP, 1 mg and 2 mg. The Office of Generic Drugs, US FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Robinul 1 mg and Robinul Forte tablets, 2 mg, respectively, of Sciele Pharma, Inc.   The total annual market sales for glycopyrrolate tablets were $26 million. glycopyrrolate tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

MediciNova, Avigen enter definitive merger agreement

MediciNova, Inc., and Avigen, Inc. announced that they have entered into a definitive merger agreement pursuant to which MediciNova's wholly-owned subsidiary will merge with and into Avigen. Completion of the transaction will permit the combination of the companies' broad neurological clinical development programs based on ibudilast (Avigen's AV-411 and MediciNova's MN-166).   Under the terms of the merger agreement, which has been approved by both companies' boards of directors, Avigen shareholders will have the right to elect to receive an amount currently estimated at approximately $1.24 per share in either cash or secured convertible notes to be issued by MediciNova. Approximately $1.19 of this consideration will be paid at the closing, and approximately $0.05 will be paid at June 30, 2010.  

Lawson, Matsumotokiyoshi Consider Venture

Japan's convenience store chain Lawson Inc. and drugstore chain Matsumotokiyoshi Holdings are considering a joint venture, sources told Kyodo News. Under a joint venture, which could come into being by the end of the year, the two companies will operate new outlets combining convenience store and drugstore formats, the sources said. Lawson, Japan's second-largest convenience store chain, and Matsumotokiyoshi, the top drugstore chain, hope by joining forces, they can boost consumer demand in the current economic downturn, the report said. The government in June allowed the sales of medicines at conveniences stores when supervised by qualified staff  

Lonza submits non-binding proposal to acquire all Patheon Inc

The Special Committee of Independent Directors of Patheon Inc. and Lonza Group AG announced that Lonza, one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries, has submitted a non-binding proposal to acquire all of the outstanding Restricted Voting Shares of Patheon at a price of USD 3.55 per Restricted Voting Share.  

North Indian pharma: Focusing on R&D and tie-ups to meet challenging conditions

The North India based listed pharmaceutical companies have established strong presence in the domestic market, highly regulated markets and emerging markets during the last couple of years with several US FDA approved facilities, high-tech R&D laboratories, focus on new lifestyle drugs and partnership with international giants.   Despite economic slowdown in international market, especially in US and Europe, these companies are going ahead aggressively in filing new products in US and Europe. The players are investing huge amounts in expansion of cGMP facilities and new technologies. However, the challenging situation with stiff generic competition, US actions against Ranbaxy and volatile foreign exchange rates are impacting overall working. The better infrastructural facilities, government support, skilled workforce and growth oriented industrial atmosphere in the North India has offered necessary boost to pharmaceutical segment. The rising custom research and manufacturing

Covance closes transaction at $145 mn to acquire Merck's Gene Expression Lab

Covance has closed its transaction with Merck to provide a broad array of genomics analysis services under a five-year $145 million contract and to acquire Merck's Seattle-based Gene Expression Laboratory. Effective August 17, 2009, Covance assumed control of the facility and the Seattle team has joined Covance. Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies with annual revenues greater than $1.7 billion, global operations in 25 countries, and more than 10,000 employees worldwide.

Apollo Hospitals Group expands international footprint to Mauritius

Apollo Hospitals Group, Asia's largest healthcare service provider, has inaugurated Apollo Bramwell Hospital - a state-of-the-art multi-specialty hospital at Moka in Maritius as a joint venture with British American Investment Co (Mtius) Limited.   Apollo Bramwell Hospital will provide world-class healthcare solutions spanning cardiology and cardiothoracic surgery; neurology and neurosurgery; nephrology; ophthalmology; neonatology and paediatrics; emergency and trauma care and cosmetic surgery, all under one roof.  

US FDA committee backs approval of DePuy Orthopaedics' Pinnacle CoMplete Acetabular Hip System

DePuy Orthopaedics, Inc, a global leader in devices for joint replacement, announced that the Orthopaedic and Rehabilitation Devices Advisory Committee of the US Food and Drug Administration (FDA) has unanimously recommended FDA approval of the Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US.   The panel's recommendation was based in part on results from a two-year controlled, randomized, blinded, prospective, multicenter, non-inferiority clinical study and laboratory testing that compared the safety and effectiveness of the Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant.

Matrix Lab's share delisted from BSE & NSE

The equity shares of Matrix Laboratories, a subsidiary of Mylan Inc, USA, has been de-listed from Bombay Stock Exchange and National Stock Exchange from today as the public share holding has fallen below 10 per cent after the buy-back offer. MP Laboratories (Mauritius) (Acquirer), a wholly owned subsidiary of Mylan and one of the promoters of the company, had initiated voluntary delisting of the shares of the company from BSE and NSE in accordance with the SEBI (Delisting of Securities) Guidelines, 2003 during June 2009. As at the end of June 2009, Mylan was holding 92.59 per cent of company's equity capital of Rs 31.27 crore. As per the buy-back offer, MP Laboratories has acquired Matrix's shares from public at a price of Rs 211 per share. Pursuant to the said delisting applications, trading in equity shares of the company has been discontinued with effect from August 14, 2009. The Matrix scrip was last quoted at Rs 209.75 on August 13, 2009 with 52-weeks peak level of Rs

FDA cracks down on ibuprofen pain relief gels

The Food and Drug Administration has issued warnings to eight companies for illegally marketing pain relief ointments containing ibuprofen. Regulators say the companies do not have federal permission to market their products, which mix the popular pain relief drug with other ingredients. While ibuprofen is available in a variety of tablets like Advil, the FDA has not approved any ointments containing the drug. The companies include: Tennessee-based Wonder Laboratories, New Mexico-based Meditrend and Alabama-based Progressive Emu Inc. They have 15 business days to respond to the FDA citations Some of the products claim they are safer than tablets. The FDA says there is no evidence supporting those claims.  

GSK's Hib vaccine Hiberix gets US FDA approval

In response to a US shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis. The Hib vaccine shortage began in 2007 when another vaccine manufacturer temporarily suspended manufacturing of its Hib containing vaccines. This led the CDC (Centers for Disease Control and Prevention) to recommend temporary deferral of the booster dose for healthy children not at increased risk for Hib disease. Earlier this summer, the CDC reinstated the routine Hib booster dose due to an increase in supply. However, supply was not sufficient to support a mass catch-up effort for the millions of children who did not receive the booster dose during the

Millipore introduces novel kit for RNA-protein binding

Millipore has launched its new Magna RIP RNA binding protein imuno precipitation kit to provide a complete solution for the entire RIP workflow. With this kit, any researcher, even those inexperienced in RNA purification, can investigate the dynamics of ribonucleoprotein assembly as it occurs inside the cell. Cells respond to stimuli by altering gene expression, and RNA-protein complexes drive almost all processes regulating gene expression at the post-transcriptional level, including splicing, nuclear export, mRNA stability, and translation. Therefore, understanding gene regulation depends on characterizing the changes in RNA binding in these various processes. Traditionally, RNA-protein interactions have been identified by screening libraries in yeast, bacteria, or by in vitro selection, all confounded by system limitations, biases, or artifacts. In contrast, data obtained from RIP shows increased biological relevance, enabling researchers to achieve their goals more quickly.  

SRL to market Rosetta's miRview diagnostic tests in India, Saudi Arabia, Qatar & UAE

Rosetta Genomics, Ltd, a leading developer of microRNA-based molecular diagnostics, and Super Religare Laboratories Limited (SRL), India's largest diagnostics network, have signed an exclusive distribution agreement for Rosetta Genomics' three currently-available diagnostic tests.   Under the terms of the agreement, SRL will market Rosetta Genomics' miRview tests in India, Saudi Arabia, Qatar, and the UAE. Samples will be sent from SRL's territories to Rosetta Genomics' Philadelphia-based CLIA-certified laboratory for analysis.   The agreement between Rosetta and SRL also envisages joint cooperation and collaboration between the two companies to conduct field trials for development of tests and assays an exchange of information for development of new technologies and leading edge diagnostic solutions. The Rosetta Genomics tests that will be distributed by SRL in India include miRview mets (to accurately identify the primary tumour site in patients with metas

Oculus Innovative launches Microcyn skin & wound cleanser with preservatives in US

Oculus Innovative Sciences, Inc, a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn Technology platform, commercialized its Microcyn Skin and Wound Cleanser with preservatives in both professional and over-the-counter formulations. The professional product is indicated for use by health care practitioners to manage the debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree wounds, grafted and donor sites. The OTC product is indicated for use in cleansing of dirt and debris from lacerations, skin abrasions, minor burns and minor irritations of the skin. Microcyn Skin and Wound Cleanser with preservatives, which received FDA 510(k) clearance in May of this year, has demonstrated rapid activity against a broad spectrum of gram-positive, gram-negative and yeast species.  

FDA Warns of Glucose Monitoring Technology

The U.S. Food and Drug Administration is warning against using some glucose monitors by patients receiving medicines containing non-glucose sugars. The FDA said its warning involves using glucose monitors that require specific test strips. "Non-glucose sugars contained in some therapeutic products such as peritoneal dialysis solutions and certain immunoglobulins can falsely elevate glucose results, which may prompt excessive insulin administration," the FDA said. "These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis." The FDA said the devices that use glucose test strips containing glucose dehydrogenase pyrroloquinoline quinine -- the chemical that reacts with the non-glucose sugars contained in some therapeutic products -- might produce false high te

Tianyin Pharma gets Chinese nod for Snaqi & Yinqiao Jiedu tabs

Tianyin Pharmaceutical Co, Inc, a manufacturer and supplier of modernized traditional Chinese medicine (TCM) based in Chengdu, China, has received approvals from the Chinese State Food and Drug Administration (SFDA) to produce Sanqi tablets in dosage form of 0.5 gram/tablet (SFDA approval number Z20093512) and Yinqiao Jiedu tablets in dosage form of 0.5 gram/tablet (SFDA approval number Z20093555).   Sanqi Tablets are a generic TCM that effectively treats traumatic injuries and stops bleeding without causing blood stasis, while also alleviating associated pain and reducing swelling. Sanqi is also used as a haemostatic for patients with internal bleeding or hemorrhagic diseases. According to Tianyin's market research and estimation, annual sales of Sanqi are approximately $73.5 million in China. Tianyin expects to gain a portion of the market share in orthopedic medicine through the production and marketing of Sanqi Tablets.

Super Religare Labs ready for swine flu screening

Super Religare Laboratories (SRL), India's largest diagnostics network, is fully prepared for a fight against the increasing number of swine flu cases in the country. SRL has ensured adequate availability of kits at its two reference laboratories in Mumbai and Gurgaon, both of which are accredited by CAP (College of American pathologist), USA and the National Accreditation Board for Laboratories (NABL), Govt. of India.   At present, SRL has about 1,000 swine flu testing kits available with it at the Mumbai and Gurgaon centres that will help in meeting the requirement of the rising problem in the state. Also, looking at the seriousness of the swine flu cases in the county Super Religare Laboratories has also decided to lower its price for the testing of swine flu in case the government invites them for screening the affected patients. SRL will be charging only Rs 4,000 per test, whereas the other private laboratories have fixed their price for Rs 10,000.  

Test May Aid Hepatitis Therapy: Doctors May Be Able to Predict Patient Response to Drugs

A newly discovered genetic marker helps identify which patients will respond well to hepatitis C treatments and which are likely to fail, scientists at Duke University report today. Armed with the information, doctors and patients could have a clearer road map as they launch treatment -- an often debilitating yearlong regimen of weekly shots and daily pills that cures only about half the time. "The therapy is unpleasant, to be sure, and that is precisely why both the clinician and patient would want the information up front," said David Goldstein, director of the Center for Human Genome Variation in Duke's Institute for Genome Sciences & Policy, and the senior author of the study. The findings are published in the journal Nature. An estimated 4million Americans have hepatitis C, a viral infection that is spread predominantly through blood. Without treatment, it causes severe liver damage and cancer. Widely divergent responses to current therapies have long p

Thermo Fisher establishes RNAi discovery grant programme to advance gene research

Thermo Fisher Scientific Inc, the world leader in serving science, has established a grant programme to award life science researchers more than $400,000 in RNA-interference (RNAi) reagents used to study genes in medical research and drug discovery. The Thermo Scientific Discovery Grant Programme will include various siRNA, shRNA and microRNA reagents from the industry-leading Dharmacon and Open Biosystems RNAi technology portfolios, marketed under the Thermo Scientific brand. Five projects will be selected based on their potential to advance science and medicine. Recent breakthroughs involving Thermo Scientific RNAi technologies include a study to find human genes associated with West Nile virus infection, the discovery of potential new targets for HIV drugs and identification of genes that appear to affect the susceptibility of human cancer cells to certain chemotherapy treatments.

Cryo-Save India to launch human adipose tissue stem cells storage services

Cryo-Save India Pvt Ltd, the wholly-owned subsidiary of the Belgium-based adult stem cell storage bank major Cryo-Save Group, is exploring options to launch services to collect and store stem cells from human adipose tissues after liposuction as a potential aid to treating diseases.   The Indian launch will be in line with the parent company's global launch of the new service by the end of 2009, according to V R Chandramouli, managing director, Cryo-Save India. The Cryo-Save, Europe's largest adult stem cell storage bank, is developing a technique called Cryo-Lip to retrieve, process and store mesenchymal stem cells (MSC) from fatty tissue, which is now considered as a waste after liposuction.

King Pharma's pain drug Embeda receives US FA approval

King Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has approved Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules for oral use, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Embeda is the first FDA-approved long-acting opioid that is designed to reduce drug liking and euphoria when tampered with by crushing or chewing.

Millipore introduces single-use Mobius CellReady 3L Bioreactor

Millipore has introduced the new Mobius CellReady 3L Bioreactor. The ready-to-use three-liter bioreactor demonstrates all the benefits typically associated with single-use processing, while incorporating standard design features familiar to customers already using bench-top, stirred-tank bioreactors.   Designed to replace traditional glass bench-top bioreactors, the CellReady 3L Bioreactor has a standard stirred-tank format for use in development and optimization of cell culture processes. This vessel design provides a higher degree of predictability during process scale-up when compared to formats utilizing alternative vessel designs and agitation methods. It features a universal design, ensuring compatibility with most bench-top bioreactor control systems. By eliminating time-consuming steps associated with cleaning, assembly, and sterilization, the CellReady 3L bioreactor significantly reduces the turnaround time typically associated with glass bioreactors.  

India has access only to Tamiflu for swine flu treatment

Tamiflu (oseltamivir) and Relenza (zanamivir) are the two drugs prescribed to treat swine flu caused by the H1N1 virus. But India has access only to Tamiflu (oseltamivir), though the mode of action for both the drugs is to block the viral receptors infecting the healthy cells.   The H1N1 virus is resistant to the drugs like amantadine, rimantadine, and other adamantanes. Both oseltamivir and zanamivir approved in 1999 by US FDA belong to a new class of neuraminidase inhibitors which are antiviral drugs to control influenza A and B viruses. The two drugs have gone through extensive clinical trials involving over 1,000 patients. Tamiflu has been successful to treat H5N1 virus (Avian Flu), is now responding positively to control H1N1 virus.  

Ranbaxy Wins FDA Approval for Generic Migraine Drug

Ranbaxy Laboratories has received final approval from FDA to manufacture and market sumatriptan succinate tablets, 25mg, and 50mg. The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Imitrex by GlaxoSmithKline. According to Ranbaxy, sumatriptan succinate 25mg and 50mg tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.  

Neurobiological terminates license & cooperation pact with Merz Pharma and CMCC

Neurobiological Technologies, Inc (NTI) has entered into an agreement to terminate its license and cooperation agreement with Merz Pharmaceuticals GmbH (Merz) and Children's Medical Center Corporation (CMCC). Pursuant to the termination of the agreement, within 10 business days Merz will make a final payment to NTI in satisfaction of all its royalty and other obligations under the license and cooperation agreement. Also pursuant to the termination agreement, NTI and Merz agreed to a mutual release of all claims related to the license and cooperation agreement. NTI also announced that it received a regularly scheduled royalty payment from Merz immediately prior to entering into the termination of the license and cooperation agreement. Under the license and cooperation agreement, as amended in 2008, NTI and CMCC have been entitled to receive quarterly royalty payments from Merz on sales of Memantine in the United States, with scheduled reductions in the royalty rates. The termi

Tianyin Wins Chinese Approval for Sanqi and Yinqiao Jiedu Tablets

Tianyin Pharmaceutical, a manufacturer of modernized traditional Chinese medicine, has received approvals from the Chinese State Food and Drug Administration to produce Sanqi tablets in dosage form of 0.5gm/tablet and Yinqiao Jiedu tablets in dosage form of 0.5gm/tablet. According to Tianyin, Sanqi tablets are a generic traditional Chinese medicine (TCM) that effectively treats traumatic injuries and stops bleeding without causing blood stasis, while also alleviating associated pain and reducing swelling. Sanqi is also used as a hemostatic for patients with internal bleeding or hemorrhagic diseases. Yinqiao Jiedu tablets are a generic TCM which are used mainly to treat acute respiratory system ailments, such as influenza and common cold. It is specifically used to clear the lungs and aid in function of the throat, the company said.  

Dr Lal PathLabs opens labs in Jalandhar, Amritsar and Panipat

Dr Lal PathLabs, India's largest medical diagnostics company, has opened three state-of-the-art pathology laboratories in Jalandhar, Amritsar and Panipat. The new labs will deliver world-class diagnostic services with the quickest turn-around time to the people of Punjab and Haryana.   The pathology major has also entered into a lab management contract with Jindal Hospital, Hissar.   Dr Lal PathLabs has two existing labs in Chandigarh and Ludhiana, six patient service centres and 150 collection centres across Punjab and Haryana. The LPL network serves more than five lakh patients in this region every year and an estimated additional 2.5 lakh patients will be benefited every year following the opening of the new labs.   The newly opened labs form a part of Dr Lal PathLab's constant endeavour to provide the best possible diagnostic facilities to every Indian. With the new centres in place, the pathology major has 40 such labs across India.  

Elan sues Biogen on Tysabri

Elan Corporation, plc has filed suit against Biogen Idec Inc in Federal Court in New York seeking declaratory and injunctive relief that certain aspects of Elan's recently announced transaction with affiliates of Johnson & Johnson comply with Elan's Collaboration Agreement with Biogen Idec for the development and marketing of Tysabri. In a letter to Elan dated July 28, 2009, Biogen Idec alleged that Elan was in material breach of the Collaboration Agreement. Biogen Idec's assertion against Elan relates to Elan's ability to obtain financing from an affiliate of Johnson & Johnson to potentially purchase Biogen Idec's Tysabri rights, if Biogen Idec undergoes a change of control. Biogen Idec made this assertion even though it was not in possession of the relevant agreement related to the Transaction at the time, which Elan has offered to share with Biogen Idec. Elan strongly believes that it is in compliance in all respects with the Collaboration Agreement.

US court awards $57 mn to Medtronic in patent dispute with AGA Medical

Medtronic, Inc. announced that a federal US district court jury in San Francisco awarded it $57 million in past damages, finding that AGA Medical Corp.'s manufacture, sale and use of its Amplatzer Occluder and vascular plug product lines infringed claims of two US patents owned by Medtronic. The jury also ordered that AGA pay Medtronic a royalty of 11 per cent on future US sales of the infringing products through 2018.  

Nabi Biopharma sells PentaStaph assets to GSK for $46 mn

Nabi Biopharmaceuticals has signed a definitive agreement for the sale of PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GlaxoSmithKline (GSK) for a total consideration of up to $46 million.   Under the terms of the agreement, Nabi will receive an initial cash payment of $20 million when the transaction closes plus an additional $26 million contingent upon four milestone accomplishments. The sale is subject to satisfaction of certain customary closing conditions by the buyer and seller prior to closing. Nabi anticipates closing the sale before year-end 2009 and completing the milestones within the next 18 months

Spectrum Pharma acquires 100% rights to RenaZorb from Altair Nanotechnologies

Spectrum Pharmaceuticals, Inc., a commercial-stage biotechnology company with a primary focus in oncology, announced that it has acquired 100 per cent rights to RenaZorb (a family of compounds represented by SPI-014, also known as RZB-014), from Altair Nanotechnologies. RenaZorb is a lanthanum-based nanotechnology compound with potent and selective phosphate binding properties, for all human and non-human indications.

Shilpa Medicare enters into JV with ICE and PCA in Italy

Shilpa Medicare Ltd, a leading active pharmaceutical ingredient manufacturer, has entered into a joint venture agreement with ICE S.r.l. and PCA, Spa of Italy. Under the agreement, it has set up a new company Raichem Medicare (P) Ltd.   Both Shilpa and ICE (Industria Chemica Emiliana), Italy have been working together for the last seven years for custom synthesis under confidentiality agreement. The success of this has led to the joint venture, stated Omprakash Inani, chairman, Shilpa Medicare.   While ICA is a recognized major manufacturer of bile acid derivative such as cholic acid which helps regulate cholesterol acid, PCA is a US FDA company manufacturing Ursodeoxycholic acid. Both the companies are the largest producers Ursodeoxycholic acid.  

Venus Remedies' Tobracef gets South African patent

Venus Remedies Limited, a Haryana-based leading research based company, has announced that the company has received patent for Tobracef from the Companies and Intellectual Property Registration Office (CIPRO), South Africa. Tobracef is indicated for the treatment of complicated mixed bacterial infection of acute pulmonary exacerbations/custic fibrosis/chronic obstructive pulmonary disease. The product is a novel fixed dose combination of cephalosporin and aminoglycoside.

Medivir's Lipsovir gets US FDA nod for cold sores

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented. Treatment is approved for adults and children 12 years or older. Like other cold sore pharmaceuticals Lipsovir will be a prescription (Rx) product in the US. The label, that is the indication text endorsed by the FDA, states "Acyclovir and Hydrocortisone Cream is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time." No product currently marketed for the treatment of cold sores has a corresponding label or has been shown to prevent an outbreak with early treatment. This gives Medivir a clear competitive edge on the US market, which is the m

Dr Reddy's launches Finrid in India

Dr Reddy's Laboratories Ltd has launched Finrid (Fentanyl Transdermal Patch) in India. Used in the management of severe to moderate pain, Finrid provides continuous systemic delivery of Fentanyl, a potent opioid analgesic for upto 72 hours. It is the first opioid transdermal patch to be developed in India.   Being a controlled substance, Finrid will be sold through an independent distribution structure and will be available across hospitals and palliative care centres in India, a company release stated. Finrid is available in a transdermal patch form, and delivers dosages of 25 mcg/hr and 50 mcg/hr depending on the patch used.

Head of Merck Vaccines Unit Will Retire

Margaret G. "Margie" McGlynn, president of Merck Vaccines & Infectious Diseases, announced her retirement yesterday, effective Nov. 1. Company spokeswoman Amy Rose said McGlynn, a pharmacist who started with Merck in 1981 as a summer intern, "indicated that she has many personal and professional aspirations that she would like to pursue." McGlynn is 49. Merck will merge with Schering-Plough in the fourth quarter. McGlynn took her current position in 2005. She managed the launch of four vaccines, including Gardasil, which protects against the virus that can cause cervical cancer, and Zostavax for shingles, as well as Isentress, an HIV/AIDS drug. Rose said that vaccine revenue quadrupled during McGlynn's tenure, from $1.1 billion in 2005 to $4.15 billion last year. But sales were higher in 2007 at $4.3 billion, and revenue from Gardasil has continued its slump this year.  

Valeant to acquire Mexican generic company Tecnofarma

Valeant Pharmaceuticals International has signed a definitive sale and purchase agreement to acquire Tecnofarma SA de CV, a privately held company located in Mexico for approximately one times sales. Tecnofarma is a producer of generic pharmaceuticals which has approximately $33 million in annual sales primarily to the government and private label markets - two segments that Valeant Mexico does not currently serve in any material way. In addition, Tecnofarma has a number of manufacturing sites including a new 160,000 sq. ft. manufacturing plant that will allow Valeant Latin America to reduce its dependence upon third party manufacturers. Finally, Tecnofarma has eighty registered products that can be introduced into the branded generic market in Mexico.

Merck to buy genomic analysis services for 5 yrs from Covance for $145 mn

Covance has entered into a definitive agreement with Merck & Co, Inc relating to the supply of genomic analysis services. Under the terms of the agreement Merck has committed to a five-year $145 million contract to purchase genomic analysis services from Covance. In addition Covance will acquire Merck's Seattle-based Gene Expression Laboratory that performs genomics services such as genotyping, gene sequencing and gene expression profiling.

Stable tablet formulation & once daily dosing regimen for Kuvan gets US patent

BioMarin Pharmaceutical Inc announced that the United States Patent Office has issued patents covering stable tablet formulation and the approved once daily dosing regimen for Kuvan (sapropterin dihydrochloride) for the treatment of phenylketonuria (PKU). The patent for stable tablet formulation expires in 2025, and the patent for the once daily dosing regimen expires in 2024.   "We believe the issuance of these two patents is significant in strengthening our proprietary position on Kuvan," said Jean-Jacques Bienaime, chief executive officer of BioMarin. "These patents provide coverage for Kuvan's formulation and approved dosing regimen that extends approximately ten years beyond orphan drug protection and we believe will prevent therapeutically equivalent competition from entering the market."   Kuvan (sapropterin dihydrochloride) Tablets are indicated in the United States to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (