Biotech Day in Review: New River/Shire Win Approval for ADHD Drug

New River Pharma (NRPH) and Shire (SHPGY) received FDA approval of Vyvanse, their partnered, abuse-resistant, ADHD drug.

Last week, Shire made a $2.6 billion cash offer to buy New River. The only holdup on the drug has been the scheduling of Vyvanse by the DEA, and it was given a Schedule II classification, which is in line with other amphetamine drugs for ADHD, but more strict than New River/Shire was originally hoping for. New River gained 7 cents to end at $63.33, and Shire rose 23 cents to close at $66.84.

Bristol-Myers Squibb (BMY) established a partnership with Adnexus to develop Adnectin candidates for cancer. BMS will make $30 million available over three years for research undertaken by Adnexus, and Adnexus can receive up to $210 million per product in milestones (for six products), plus royalties. Adnexus also has a limited right to co-promote the first product. BMS moved up 14 cents to $27.19.

Lilly (LLY) received FDA approval of Cymbalta as a treatment for generalized anxiety disorder. Cymbalta, a serotonin/norepinephrine reuptake inhibitor, is already approved for use with major depressive disorder and neuropathic pain.

Lilly also announced a new trial of sepsis drug Xigris. The test will seek to define the patients who are most likely to benefit from the drug and to clarify the benefit/risk profile. In Europe, the drug was licensed in August 2002 under exceptional circumstances, which mandates an annual review. Lilly was 19 cents higher at $54.40.

MDS [MDS] sold its Canadian lab business to Borealis Infrastructure, the investment entity of Ontario Municipal Employees Retirement System, for $1.325 billion (Canadian). MDS announced that it would spend $500 million (Canadian) to buy back its own shares in a Dutch auction. MDS no longer has a lab business, but it has become a global life sciences company. MDS fell 35 cents to $21.47.

Hollis-Eden (HEPH) published results from a pre-clinical test showing that Neumune was effective in improving survival in monkeys who suffered from radiation-induced myelosuppression. According to Hollis-Eden, these data were the first published results that show a single agent improved survival in irradiated primates. Hollis-Eden was off 5 cents at $5.46.

Cell Therapeutics (CTIC) said Xyotax produced a major response in 24% of prostate cancer patients. All the patients in the trial had androgen independent prostate cancer, and each had failed a previous treatment with taxane chemo. Cell Therapeutics moved up 3 cents to $1.58.

AstraZeneca (AZN) began a Phase III trial of Zactima (vandetanib), a potential treatment for non-small cell lung cancer [NSCLC]. The drug will be given as a second-line therapy as an adjunct to Alimta to patients with metastatic disease after a first-line therapy has failed. This trial is the fourth Phase III test of Elaprase for NSCLC. AstraZeneca gained 11 cents to close at $57.30.

Samaritan Pharma [LIV] will distribute Elaprase, a Shire [SHPGY] treatment for Hunter’s disease, in Greece and Cyprus. No financial details were disclosed. Shire won European approval for the enzyme replacement therapy in January 2007. Elaprase was launched in the U.S. in July 2006. Samaritan ended with a 2 cent gain at $.26.

Biotech slipped slightly in the opening session of the week. The Centient Biotech 200™ edged 2 points lower to 4052, a loss of .05%. That was better than the broad market, as the S&P 500 was off by .13% and Nasdaq was down .42%.

Disclosure: none.