Replies to post #3130 on Biotech Values

[DewDiligence]

Re: CEPH, BRL forge Actiq deal:

After listening to CEPH’s CC on Tuesday, I think the analysts and the market got this deal all wrong.

Because CEPH’s main patent for Actiq is set to expire in late 2006 (with pediatric exclusivity possibly extending to early 2007), CEPH is ceding essentially nothing in the BLR licensing deal. Rather than a “government-mandated authorized generic” (the characterization I used in my previous post), this whole deal looks like a charade to please the anti-competition cops at the FTC.

Score one for CEPH.

[rkrw]

Competition for oravescent fentanyl.

Press Release Source: Endo Pharmaceuticals Inc.


Endo Licenses the Rights to Develop and Market Proprietary Sublingual Fentanyl Product From Orexo
Wednesday August 18, 7:00 am ET


CHADDS FORD, Pa., Aug. 18 /PRNewswire/ -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP - News), announced that it has entered into an agreement granting Endo the exclusive rights to develop and market Orexo AB's (a privately held Swedish company) patented sublingual muco-adhesive fentanyl product (Rapinyl(TM)) in North America. Rapinyl(TM) is an oral, fast-dissolving tablet of fentanyl intended for the treatment of breakthrough cancer pain.
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"We are delighted to add this novel proprietary product to our portfolio," said Carol A. Ammon, chairman and chief executive officer of Endo. "We believe that this product is an excellent strategic fit for us and reinforces our continued leadership position in pain management. The benefits of Rapinyl(TM) are believed to include both a fast onset of action and added convenience, which we believe will improve compliance in cancer patients who experience breakthrough pain."

"We are very pleased to be partnering Rapinyl(TM) with Endo Pharmaceuticals for the North American market," said Zsolt Lavotha, president and chief executive officer of Orexo AB. "Endo Pharmaceuticals is a market leader in pain management products, with a strong reputation for research and development as well as marketing and sales. We believe Endo Pharmaceuticals is the ideal partner to fully exploit the potential of Rapinyl(TM) in North America."

Rapinyl(TM) is based on Orexo's unique patented technology for sublingual administration. This novel pharmaceutical preparation is believed to provide rapid absorption of the active substance and a fast onset of action. Currently in Phase II clinical development, this product has demonstrated enhanced absorption characteristics and is intended for the management of breakthrough pain in opioid-tolerant cancer patients. Endo anticipates that it will commence Phase III clinical trials in 2005.

The agreement provides for Endo to make an up-front license fee payment of $10 million, in addition to other license fees and payments based on development and regulatory milestones, which may total up to $22.1 million through FDA approval of Rapinyl(TM)'s New Drug Application. The agreement also provides for double-digit royalties upon commercial sales and may include sales milestones if defined sales thresholds are achieved.

About Endo

A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at http://www.endo.com.

About Orexo

Orexo AB is a product-focused drug delivery company. Orexo develops, documents and registers innovative pharmaceutical products with clinical benefits based on patented, proprietary technology platforms. The products are developed on the basis of defined therapeutic needs with the objective of reaching a global market. The company is based in Uppsala, Sweden. http://www.orexo.com

[DewDiligence]

CEPH Receives ‘No Sweat’ Approvable Letter for Buccal Fentanyl

[Fentora, which was previously known as OraVescent fentanyl, is the drug that CEPH picked up in the 2004 acquisition of Cima Labs, and it has the potential to make CEPH’s Actiq fentanyl lollipop all but obsolete. (CEPH will lose marketing exclusivity on Actiq in December 2006 due to a prior FTC-sanctioned agreement with BRL [#msg-3776755, #msg-9524014]. According to the PR below, BRL has exercised its option to use CEPH as its manufacturer for generic Actiq.) The approvable letter for Fentora received today sounds like no big deal, and a product launch seems likely as soon as the early fall.]

http://biz.yahoo.com/prnews/060629/phth054.html?.v=34

>>
Cephalon Receives Approvable Letter for FENTORA(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer

Thursday June 29, 5:20 pm ET

FRAZER, Pa., June 29 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for FENTORA(TM) (fentanyl buccal tablet) [C-II]. The company submitted a new drug application (NDA) in August 2005, seeking to market FENTORA for the treatment of breakthrough pain in opioid-tolerant patients with cancer.

"We are pleased with FDA's response and are working closely with the agency to secure final approval of this important new medication," said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations. "We believe FENTORA will extend the leadership position of Cephalon in the development of innovative medications for the management of breakthrough pain in patients with cancer."

Cephalon intends to submit a response to the FDA by the end of July. The company expects the FDA to classify this response as a Class I resubmission under which the FDA will seek to complete its review within 60 days of the resubmission. FDA has indicated that no additional safety or efficacy data are required and that the labeling has been essentially finalized.

FENTORA is specifically designed to manage breakthrough pain, a common component of chronic pain that can be characterized by its intensity, rapid onset, and relatively short duration. The medication is a simple-to- administer sugar-free, fentanyl buccal tablet that can be discretely placed between a patient's upper cheek and gum (buccal cavity). Its proprietary OraVescent® technology uses an effervescent reaction to produce transient shifts in pH levels in the area surrounding the tablet which is thought to enhance the rate and extent of fentanyl absorption through the buccal mucosa. The OraVescent technology permits rapid and efficient delivery of the majority of the medication directly into the bloodstream.

The NDA submission for FENTORA included data from 13 clinical studies. The pivotal double-blind, placebo-controlled, variable-dose study assessed the safety and efficacy of FENTORA in adult patients with breakthrough pain who were already receiving opioid medication for treatment of their moderate-to- severe cancer pain. In the pivotal study, FENTORA provided clinically significant decreases in pain intensity and greater pain relief in as little as 15 minutes. The Phase 3 safety and efficacy studies demonstrate that FENTORA was generally well tolerated. The most common adverse effects observed were typical of those seen with opioids and in patients with cancer being treated with chemotherapy, including nausea, dizziness, headache, fatigue, vomiting, and somnolence. The most serious adverse events associated with all opioids are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. All patients should be followed for symptoms of respiratory depression. Opioid side effects should be expected and managed accordingly.

On a separate matter, Barr Laboratories, Inc. has invoked its option under the license and supply agreement with the company to have Cephalon manufacture for it a generic version of ACTIQ® (oral transmucosal fentanyl citrate) [C- II]. Cephalon expects to deliver bulk units to Barr, and Barr will be responsible for all packaging and labeling of the product.

Breakthrough Pain

Approximately 50 million Americans suffer from chronic pain, a condition that consists of two distinct components: persistent pain, which is pain that is continuous throughout the day, and breakthrough pain, which is a transitory flare of moderate-to-severe pain in patients with otherwise stable persistent pain. Breakthrough pain can reach peak intensity in as little as three minutes and typically lasts for 30 to 60 minutes. It may occur during a specific activity, spontaneously with no apparent cause, or when the dose of the persistent pain medicine wears off. An estimated 64 percent of all cancer patients treated for persistent pain - and up to 74 percent of patients treated for persistent pain from other conditions such as low back pain, diabetic neuropathy, and osteoarthritis - will experience breakthrough pain. Breakthrough pain can have a profound impact on an individual's physical and psychological well being. It can increase the economic burden on both patients and the healthcare system.

Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company's headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters are located in Maisons-Alfort, France.
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