Mar
16

Active Biotech gets boost from late-stage oral MS program

Posted under Active Biotech, Biogen Idec, Blog, Companies, Diagnostics, Funding, Gilenya, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Teva Pharmaceutical Industries, Universities, Videos by Ryan McBride

Active Biotech's ($ACTI) shares jumped after its partner Teva Pharmaceutical ($TEVA) touted results of a late-stage trial for an oral multiple sclerosis drug under development with Active. While the companies' body of data on the MS pill, laquinimod, have failed to impress analysts, Teva plans to push ahead with an application to gain European approval of the drug in the second half of this year.

Teva plugged the program's results from the Phase III "Allegro" trial, in which laquinimod reduced annual relapse rates, stymied disability progression and lowered loss of brain tissue in MS patients on the drug. Those results appeared in the prestigious New England Journal of Medicine on Thursday, when Israel-based Teva trumpeted plans for the European regulatory filing.

The news was enough to get Yilmaz Mahshid, an analyst at Pareto Securities, to raise the price target on Active's shares to 65 kronor from 50 kronor, Bloomberg reported. The news service said that the Lund, Sweden-based biotech's shares jumped as much as 13% today.

Despite the results of the Allegro study, Teva and Active remain behind in the race to advance oral MS drugs. Novartis ($NVS), of course, got to market first with its MS pill Gilenya. Biogen Idec ($BIIB) has wowed analysts with data from its MS drug BG-12 and last month filed an NDA in hopes of securing FDA approval of the drug later this year. There's blockbuster market potential for drugs that MS patients can take orally, as opposed to the injected MS treatments that now dominate the market.

Even if Teva and Active's laquinimod gains European approval, the nod would likely trail those of its rivals and Teva would still face the challenge of gaining reimbursements from governments and insurers in Europe.

- here's Teva's release
- see Bloomberg's report

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Mar
09

UPDATED: Teva, OncoGenex amp up Phase III fight against prostate cancer

Posted under Blog, Companies, custirsen, Diagnostics, Funding, Medical Devices, Medical Supply, OncoGenex, Pharmaceuticals, Prostate Cancer, Startups, Teva Pharmaceutical Industries, Universities, Videos by Ryan McBride

As the field of contenders advancing new drugs for prostate cancer gets crowded, OncoGenex Pharmaceuticals ($OGXI) and partner Teva Pharmaceutical ($TEVA) are putting additional muscle behind their late-stage horse in the race, a compound called custirsen.

OncoGenex revealed the revamped custirsen strategy Thursday afternoon, saying the Bothell, WA, company and Teva plan to start a new Phase III trial for the drug in combination with Sanofi's ($SNY) chemotherapy drug Jevtana with the goal of improving survival of prostate cancer patients. The companies are nixing a trial called Saturn that was intended to test custirsen with reduction in cancer-related pain as the main endpoint. Meanwhile, the developers are boosting enrollment from 800 patients to 1,000 patients in a separate Phase III trial called Synergy, which aims to test custirsen in combination with chemo in patients with castration-resistant prostate cancer.

Prostate cancer--which is the second-most common cancer among U.S. men and is projected to cause 28,170 deaths in the country this year--has garnered lots of interest among biopharma companies. OncoGenex's retooled trial plan comes on the heels of Johnson & Johnson's ($JNJ) announcement of early success in a trial with the drug Zytiga in prostate cancer patients who had not yet been treated with chemo, a development that could greatly expand the market for the drug. And Medivation ($MDVN) and Exelixis ($EXEL) are in the hunt with drugs to serve segments of the prostate cancer market.

"I think there's going to be a really important need for an agent like custirsen to improve on chemotherapy as the other agents migrate to the pre-chemotherapy setting," OncoGenex CEO Scott Cormack said Thursday on a conference call, as quoted by Xconomy.

As Xconomy reports, OncoGenex expects to shell out more cash this year to bankroll the updated trial plan for custirsen, essentially doubling down on its original bet on the program to see that it has its best shot at FDA approval.

- here's the release
- get more in Xconomy's article

Editor's Note: Updated to clarify the type of prostate cancer that will be treated in the companies' "Synergy" trial.

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Feb
15

Teva looks set for a new round of M&A deals

Posted under Blog, Cephalon, Companies, Diagnostics, Funding, Jeremy Levin, laquinimod, Medical Devices, Medical Supply, Pharmaceuticals, Shire Pharmaceuticals, Startups, Teva Pharmaceutical Industries, Universities, Videos by John Carroll

Don't be too surprised if Teva starts to make fresh headlines on the M&A side of the business. CEO Shlomo Yanai is telling reporters the company is acutely aware of just how badly it needs to diversify its product base to cover falling revenue from its MS franchise. And with star Bristol-Myers Squibb ($BMY) dealmaker Jeremy Levin taking the helm from Yanai in May, analysts are buzzing about whether Teva ($TEVA) is thinking of pulling the trigger on a Shire takeover.

"Our answer is not just in developing drugs but in reducing our dependence on this product," Yanai told a news conference today, according to a report in Reuters. And Levin's looming arrival indicates for many that Teva sees a big future on the branded side of the biopharma business.

Revenue from branded drugs jumped 68% in the fourth quarter, a boost delivered by new drugs acquired in its Cephalon takeover. "During 2011 we made important progress in reaching our strategic goals with the acquisitions of Cephalon and Taiyo, and the creation of a unique joint venture with Procter & Gamble," Yanai told a news conference while covering the company's fourth quarter results. Its profits dropped 34% on acquisition costs.

Teva has had its own problems in drug development. Laquinimod, its next-gen MS treatment, recently flunked a late-stage study. And now Teva is working with regulators to design a new study for the therapeutic. Yanai says that Teva has a strong pipeline of experimental drugs.

- read the Reuters report
- get the Dow Jones story

Special Report: Jeremy Levin - The 25 most influential people in biopharma today

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Feb
15

Teva looks set for a new round of M&A deals

Posted under Blog, Cephalon, Companies, Diagnostics, Funding, Jeremy Levin, Medical Devices, Medical Supply, Pharmaceuticals, Shire Pharmaceuticals, Startups, Teva Pharmaceutical Industries, Universities, Videos by John Carroll

Don't be too surprised if Teva starts to make fresh headlines on the M&A side of the business. CEO Shlomo Yanai is telling reporters the company is acutely aware of just how badly it needs to diversify its product base to cover falling revenue from its MS franchise. And with star Bristol-Myers Squibb ($BMY) dealmaker Jeremy Levin taking the helm from Yanai in May, analysts are buzzing about whether Teva ($TEVA) is thinking of pulling the trigger on a Shire takeover.

"Our answer is not just in developing drugs but in reducing our dependence on this product," Yanai told a news conference today, according to a report in Reuters. And Levin's looming arrival indicates for many that Teva sees a big future on the branded side of the biopharma business.

Revenue from branded drugs jumped 68% in the fourth quarter, a boost delivered by new drugs acquired in its Cephalon takeover. "During 2011 we made important progress in reaching our strategic goals with the acquisitions of Cephalon and Taiyo, and the creation of a unique joint venture with Procter & Gamble," Yanai told a news conference while covering the company's fourth quarter results. Its profits dropped 34% on acquisition costs.

Teva has had its own problems in drug development. Laquinimod, its next-gen MS treatment, recently flunked a late-stage study. And now Teva is working with regulators to design a new study for the therapeutic. Yanai says that Teva has a strong pipeline of experimental drugs.

- read the Reuters report
- get the Dow Jones story

Special Report: Jeremy Levin - The 25 most influential people in biopharma today

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Active Biotech gets boost from late-stage oral MS program

UPDATED: Teva, OncoGenex amp up Phase III fight against prostate cancer

Teva looks set for a new round of M&A deals

Teva looks set for a new round of M&A deals