Biotech Day In Review: Sanofi Loses Lovenox Patent

Sanofi-Aventis (SNY) lost a patent battle in California over its $2.5 billion anti-clotting drug, Lovenox.

The defeat opens the battle for a generic, but that, in turn, opens up the battle of how to approve a generic version of a biologic drug, an issue that the FDA has been studiously avoiding.

Momenta (MNTA) has been thought to have the inside track on producing a generic version of Lovenox (characterizing the complex sugars in the drug is a specialty for Momenta, and it has spent considerable energy on the project), but the news took a bigger toll on Momenta than on Sanofi-Aventis. Sanofi-Aventis slipped 55 cents lower to $43.78, but Momenta lost 20% of its value, falling $4.03 to $16.10.

Gilead (GILD) and Achillion Pharma (ACHN) will discontinue development of GS 9132 for hepatitis C in favor of a similar drug, currently known as ACH-1095. In a Phase Ib/II trial, GS 9132 was effective in lowering the viral load of hepatitis C, but it also increased the level of serum creatinine, which shows it inhibited kidney function. The problem disappeared after use of the drug was discontinued. But Gilead and Achillion decided to pursue development of another compound with a similar NS4A antagonist mechanism, looking to find a drug that is as effective but has fewer side-effect problems. The difficiulty is that the new drug is in pre-clinical development, so the decision was a considerable setback in terms of achieving revenues soon. Achillion took a big hit on the news, dropping 51%. It fell $9.12 to $8.87. Gilead was off $1 at $71.16.

Neurobiological Technologies (NTII) updated its progress with Viprinex, a stroke drug that is derived from the venom of the Malayan pit viper. A definbrinogenating agent, Viprinex is in two placebo-controlled Phase III trials, each with a goal of 650 patients, which have been underway since November 2005. The trials will continue into 2008. Unlike earlier Phase III tests, the current ones use a smaller dose, given in a two-to-three hour infusion. The goal is to lower fibrinogen rapidly without causing prolonged low levels of fibrinogen, which can create safety problems. Neurobiological Technologies rose 8 cents to $2.73.

Merck (MRK) released data from a long running trial of its remaining COX-2 drug, Arcoxia, which has never been approved in the US, although it is available in other parts of the world. The data showed that Arcoxia caused fewer episodes of upper gastrointestinal events than diclofenac, a widely-prescribed non-steroidal anti-inflammatory. There was no word on any cardiovascular side effects. The side effect worries have kept Arcoxia from the U.S. market and doomed Vioxx, also a COX-2 medication. Patients who had recently undergone any recent cardiovascular procedures were excluded from the trial. Merck submitted its NDA for Arcoxia in December 2003. The FDA has sent an Approvable letter for Arcoxia; Merck has responded to the FDA’s concerns; and the FDA is now expected to make a decision on final approval by the end of April 2007. Merck slipped 10 cents lower to $43.82.

QLT (QLTI) and Sanofi-Aventis [SNY] will pay $157.5 million to settle a patent case for Eligard, a hormonal treatment for advanced prostate cancer. The money will go to litigants Tap Pharma, Takeda Chemical and Wako Pure Chemical. QLT will pay $112.5 million and Sanofi the remaining $45 million. As part of the settlement, the two companies will have the right to profit from Eligard in the future. QLT actually moved higher on the news, rising 14 cents to $9.54.

Optimer (OPTR), an antibiotic company with two drugs for diarrhea in clinical development, priced its IPO at $7, which was below a lowered range (see story). Originally, the company said it intended to seek to place its shares in a $12-$14 range. The stock did well in open market trading, trading up $1.50 to $8.50, a 21% increase.

Stocks moved lower today across a broad front. The Centient Biotech 200™ fell 24 points to 4051, a loss of .58%. The S&P 500 moved lower by .58% and Nasdaq was off by 1.16%.

Disclosure: none.