Subscribe to Print Edition | Tue., July 15, 2008 Tamuz 12, 5768 | | Israel Time: 02:10 (EST+7) web haaretz.com   Back to Homepage Rosner's Domain Diplomacy Defense Jewish World Opinion National Print Edition Car Rental Books Peres Conference Business Real Estate Easy Start Travel Week's End Anglo File

Teva trips hard over generic Copaxone By Yoram Gabison, TheMarker and News Agencies Tags: Teva Four days after its hopes of extending its lucrative Copaxone patent for another three years were dashed last week, Teva Pharmaceuticals suffered another major blow at the end of last week - and its stock dove in response. Last Friday Teva shares dropped 7.2% on the Nasdaq on a huge turnover of 2.75 times normal. Yesterday, it was the turn of Tel Aviv investors, and Teva plunged 6.4% on Ahad Ha'am in response. The bad news was that Momenta Pharmaceuticals announced last Friday that U.S. regulators had accepted for review its generic version of Teva's multiple sclerosis drug Copaxone, sending Momenta shares up nearly 12 percent. Momenta, a biotech firm, and its partner, the Sandoz unit of Novartis AG, submitted a generic Copaxone application to the U.S. Food and Drug Administration and the FDA accepted its filing for review. Advertisement Copaxone, known generically as glatiramer acetate, is an injected medicine. Copaxone sales in North America reached $1.37 billion during the first quarter, accounting for 53% of Teva's sales in the region. The drug accounted for $667 million, or 26% of Teva's European sales. All together Copaxone is responsible for 20% of Teva's net profits in 2007. Teva said it expects a formal patent challenge and said it will file a lawsuit to stop the companies from making a generic version and it intended to sue Momenta and Sandoz for patent infringement. Teva, itself is a large manufacturer of generic drugs, has maintained it has patent protection on Copaxone in the United States until May 2014 and in much of Europe until 2015. Teva very often challenges patents held by other pharmaceutical companies. Momenta, based in Cambridge, Massachusetts, said the generic Copaxone application asserts that the Teva patents are invalid or in some ways unenforceable. Teva repeated its claims that Copaxone is a difficult product to replicate. It said standard equivalence studies for generic applications will be insufficient to get approval for a Copaxone generic, and full clinical trials will be required. Many analysts agreed with Teva and said the complexity of Copaxone's makeup means a generic will be challenging to pull off. Teva said chances are high the FDA will require clinical studies for the generic version to prove its safety, and such tests could not be completed before the patent expires in May 2014. "While the road to generic Copaxone is likely to be a long one, given the contribution of Copaxone to Teva's earnings, we expect the uncertainty around it to weigh on [Teva] shares," UBS analyst Ricky Goldwasser said in a research note. Goldwasser estimated that Copaxone provides 25 percent to 30 percent of Teva's earnings. Teva shares also fell last month after Mylan said it had signed a licensing and supply deal with India's Natco Pharma for its own generic version of Copaxone. But Mylan and Natco have yet to file a request with the FDA over Copaxone, so the Momenta announcement is still a much greater threat. Earlier last week, Teva released study results showing a 40-milligram version of Copaxone did not prove more effective than the current 20-milligram dose, raising concerns about the company's ability to extend the franchise and its patent lifetime. "Teva is committed to vigorously defending its intellectual property rights against infringement wherever they are challenged," the company said, in a statement. "Teva intends to file a lawsuit for patent infringement against Momenta/Sandoz within the 45-day period provided under the Hatch-Waxman legislation." The lawsuit will trigger a stay of FDA approval for any generic version of Copaxone, which will last either 30 months or until a court decision, whichever comes first. Goldman Sachs analyst Randall Stanicky reaffirmed a Buy rating for Teva, saying the patent challenge poses no near-term threat. The nature of Copaxone makes it difficult to replicate in a generic form, he added. Deutsche Bank wrote: "With Copaxone increasingly becoming a larger contributor to Teva's corporate profits, an estimated 24% in 2008 to 32% in 2010, investor sensitivity has recently become justifiably heightened regarding this product." Deutsche Bank downgraded Teva's shares to Hold last Monday following the news of the CopaxonePhase 3 trial failure. However, it did nor further reduce Teva's ratings, as it does not believe there is a real threat in the short to medium term for several reasons, including the complexity of formulating the Copaxone generic, high regulatory hurdles and chances of a settlement. Cowen & Co analyst Ken Cacciatore said the complexity of Copaxone will likely mean it will be treated as a biotech medicine when it comes to approving generic rivals. U.S. lawmakers are weighing legislation to create rules for approving generic versions of biotech drugs. Cacciatore said the legislation was likely to pass in late 2009 and demand some form of clinical studies, leading to an "extended delay" for companies seeking to market generic Copaxone. Bookmark to del.icio.us   History undersea Israeli lifeguard stumbles upon ancient relic during morning swim. Elections, Hebrew style U.S. presidential hopefuls use Hebrew to woo the Jewish community.

Read & React Obama: I used 'poor phrasing' in undivided Jerusalem remark Responses: 237 Syria sources to Haaretz: We'll grant no goodwill gestures to weak Olmert Responses: 51 Syria's Assad: Israel will pay a direct price for attacking Iran Responses: 75 Was building city of Modi'in a mistake? Responses: 44 More Headlines 22:49 Olmert: Hezbollah report on fate of Ron Arad is 'absolutely unsatisfactory' 01:39 Ahmadinejad: direct talks with U.S. possible in 'near future' 17:42 Barak: UN resolution on Lebanon war is a failure 00:57 Controversial New Yorker cover depicts Obama as Muslim, wife as armed terrorist 22:29 VIDEO: How Olmert and Assad dodged an unwanted Paris handshake 19:44 Noam Shalit: Don't free Palestinians while my son still held in Gaza 01:23 Israeli teams tell Diaspora Jews: Make aliyah, for soccer's sake! 23:19 Despite no confidence vote, Olmert won't dismiss Labor ministers 20:03 Hamas spokesman says Tony Blair to visit Gaza this week 14:08 Iran decries contacts between Syria and 'illegitimate' Israel 23:09 Asbestos-linked cancer 10 times more prevalent in Nahariya 17:43 New film tells tale of Palestinian killed in error by IDF who went on to save Israeli lives 21:19 American women pack up their lives, move to Israel for love Previous Editions Select Day 14 jul 13 jul 11 jul 10 jul 09 jul 08 jul 07 jul 06 jul 04 jul 03 jul 02 jul 01 jul

Special Offers Advertisement Fattal Hotel Chain Perfectly located hotels on best resorts of Israel. Israel's Premier Real Estate Website www. israel-property.com Dan Hotels Israel Live the Legend & experience an Unforgettable Summer Vacation Yossi Avrahami Presents: New Luxurious Projects in North Tel Aviv & Eilat Holyland Park Jerusalem Apartment Tower World Class Luxury Right In the heart of Tel-Aviv The Meier on Rothschild tower Your vacation starts here Israel Travel Center Guaranteed Lowest Rates Hebrew Summer courses From $39.95 ISRAEL BONDS Build Israel Israel bonds - a multi-purpose way to celebrate Israel's 60th Eldan Rent a Car Israel's leading car rental company offers you a 20% discount on all online reservations Junkyard Junk a car - get free towing nationwide and a tax-deductible receipt

Home | TV | Print Edition | Diplomacy | Opinion | Arts & Leisure | Sports | Jewish World | Underground | Site rules |

Real Estate in Israel | Travel to Israel with Haaretz | Hotels Israel | Restaurants Israel | Tourist attractions Israel | Shops Israel

birthright Israel | Search engine marketing

Haaretz.com, the online edition of Haaretz Newspaper in Israel, offers real-time breaking news, opinions and analysis from Israel and the Middle East. Haaretz.com provides extensive and in-depth coverage of Israel, the Jewish World and the Middle East, including defense, diplomacy, the Arab-Israeli conflict, the peace process, Israeli politics, Jerusalem affairs, international relations, Iran, Iraq, Syria, Lebanon, the Palestinian Authority, the West Bank and the Gaza Strip, the Israeli business world and Jewish life in Israel and the Diaspora.

© Copyright  Haaretz. All rights reserved