Replies to post #49347 on Biotech Values

[DewDiligence]

A minor but material misstatement from Reuters:

http://www.reuters.com/article/topNews/idUKL0923648620070709?rpc=44

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Rivaroxaban works by blocking a protein called Factor Xa, which plays an early role in the chemical process leading to blood clots.
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Actually, FXa’s role is not really “early.” Rather, FXa is the pivot point in a feedback loop that greatly amplifies the production of thrombin.

[DewDiligence]

Bayer Plans 50,000-Patient (!) Study for Rivaroxaban

[Rivaroxaban, from Bayer and JNJ, is one of the candidates vying to supersede warfarin as the SoC oral anticoagulant for chronic use (#msg-18759853). Rivaroxaban is similar to Apixaban from BMY and PFE (#msg-21044973) but is given only once daily instead of BID. Rivaroxaban is also further along in development. The study described in this newswire will be the largest ever undertaken by Bayer, the largest ever undertaken for any anticoagulant, and one of the largest studies ever undertaken by anyone in any indication.]

http://www.reuters.com/article/marketsNews/idUKL0671513120071106

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Tue Nov 6, 2007 5:28am EST

LEVERKUSEN, Germany, Nov 6 (Reuters) - Bayer is planning a late-stage study for its promising blood-clot drug rivaroxaban for hospitalised patients with internal diseases, the German drugs and chemicals group said on Tuesday.

"It is planned for a total of about 50,000 patients to take part in these studies, making it the largest clinical study programme Bayer has ever undertaken," Chief Executive Werner Wenning told reporters. Wenning said rivaroxaban, which the company wants to market under the trade name Xarelto, is the most promising product in its pipeline.

Rivaroxaban's current indications are prevention of venous thromboembolism, treatment of deep-vein thrombosis, stroke prevention in atrial fibrillation and acute coronary syndrome.

Bayer has already submitted the first registration applications in Europe to market rivaroxaban for prevention of venous thromboembolism following major orthopedic surgery.

"Market introduction in Europe and submission of the registration application in the United States are planned for 2008," Wenning said.

Rivaroxaban is being jointly developed by Bayer and a unit of Johnson & Johnson (JNJ).

Bayer expected annual peak sales potential of rivaroxaban to exceed 2 billion euros.
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[DewDiligence]

JNJ Reports Phase-3 Rivaroxaban Data in Knee Surgery

[Top-line results from this trial of Rivaroxaban vs Lovenox were reported in July (#msg-21044989), and today’s PR provides little in the way of additional information. The main point is that Rivaroxaban, an oral once-daily FX inhibitor, has the potential to be a very big-selling drug in both acute and chronic indications. (Phase-3 data for the chronic indications are still a couple of years off, however.]

http://biz.yahoo.com/bw/071208/20071208005019.html

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Pivotal Phase III Data Showed Rivaroxaban Was Statistically Superior to Enoxaparin in Preventing Venous Thromboembolism (VTE) in Patients Following Hip Replacement Surgery

Saturday December 8, 10:00 am ET

Head-to-Head Study Demonstrated Similar & Low Rates of Major Bleeding for Both Drugs

ATLANTA--(BUSINESS WIRE)--Results from a Phase III trial in patients undergoing total hip replacement surgery presented today showed that administration of the oral, once-daily, investigational anticoagulant, rivaroxaban, was statistically superior to once-daily subcutaneous administration of enoxaparin, the current standard of care in preventing venous thromboembolism (VTE) in patients following hip replacement surgery. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

Data from the RECORD1 study show that rivaroxaban demonstrated a 70% relative risk reduction (RRR) (p<0.001) in total VTE when compared with enoxaparin, and an 88% RRR (p<0.001) in major VTE. Rivaroxaban demonstrated a similar rate of both major bleeding (0.3% and 0.1%, respectively, p=0.178) and non-major bleeding (5.8% and 5.8% p=1.000) compared to enoxaparin.

These data were released today at a press conference during the 49th Annual Meeting of the American Society of Hematology (ASH) by Dr. Bengt Eriksson, Orthopedic Surgeon at the Sahlgrenska University Hospital/Östra, Gothenburg, Sweden, and Principal Investigator of the RECORD1 clinical trial. In addition, Dr. Eriksson will present the RECORD1 results at the major plenary session on Sunday, December 9th.

Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from the prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.

The RECORD1 (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial evaluated the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatment groups was five weeks. The primary endpoint was total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality) and the main secondary endpoint was major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death).

Further Phase III data evaluating rivaroxaban in major orthopedic surgery – including results from the RECORD2 and RECORD3 clinical trials – will be presented during oral sessions on Monday, December 10th at the ASH meeting in Atlanta. The corresponding abstracts (#307 and #308) may be viewed online at the ASH website at www.hematology.org/meetings/abstracts.cfm.

About Rivaroxaban

To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.

Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the United States is planned in 2008, where upon approval, it will be commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.
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