The 28 day round-up

Despite the rumblings of layoffs, downturns, redundancies and bailouts, February seems to have been a good month for drug approvals globally. Following are some noteworthy developments.

-Matrix Labs received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates. A WHO approval indicates that a drug meets international safety, efficacy and manufacturing quality standards. With such status, Matrix can sell the treatment in most countries outside the United States and Europe. The company's emphasis on producing affordable products has allowed it to drive down the average annual cost per patient of effective therapies. Approximately 30% of HIV/AIDS patients in the developing world depend on Matrix's ARV products.

- The US FDA has approved ATryn® (Antithrombin [Recombinant]) for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. The GTC Bio & Ovation Pharma collaboration is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the U.S. Along with the approval of ATryn, the FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind for the regulation of a genetic construct stably integrated into the genome of genetically engineered animals. This is now required for a recombinant technology used to develop transgenic animals, such as the goats that produce recombinant antithrombin.

-Good news for patients with osteoarthritis of the knee. The FDA has finally approved Genzyme's Synvisc-One which could potentially change the face of viscosupplementation therapy. Viscosupplementation is a procedure in which hyaluronic acid or a derivative such as hylan G-F 20 is injected into the knee joint to replace synovial fluid that typically becomes degraded in patients with osteoarthritis. Synvisc-One is an important therapy for OA of the knee because it delivers long-term pain relief (upto 6 months) through a single injection without the systemic side effects that can be caused by steroids and anti-inflammatory medication.

-Over 5 million gout patients with hyperuricemia have a new treatment option for the first time in 40 years. Teijin Pharma's new molecular entity, Febuxostat, is licensed to Takeda for marketing in the US where it will be available as ULORIC.

- The European Commission has granted marketing authorisation for Servier's Valdoxan(R) /Thymanax(R) (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes. Valdoxan is the first antidepressant with melatonin receptor (MT1) and (MT2) agonist properties and 5-hydroxytryptamine (serotonin) receptor 2C (5-HT2C) antagonist properties. This unique receptor profile of Valdoxan allows for the first time the restoration of the circadian rhythms of depressed patients. Valdoxan's mechanism of action is unlike those of the commonly-prescribed antidepressants, the SSRIs and SNRIs, as Valdoxan exerts its antidepressant efficacy without having an impact on serotonin levels.

-Dapoxetine has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 years of age

-A big bump for companies in Canada, as some potential major earners received approval. The 44 NOC's issued by Health Canada included- Lilly's Cymbalta for Generalized Anxiety Disorder; Schering Plough's much anticipated contraceptive NuvaRing; Shire's Vyvanse for ADHD; Wyeth's antidepressant Pristiq; and a new indication for Avastin by Roche. The increasing number of drug submissions in Canada is a sign that manufacturers now consider the Canadian market to be substantial and profitable enough to hit those earning targets despite price controls, a public payer system, and generics friendly IP laws.