Replies to post #34463 on Biotech Values

[donotknowityet]

It is not necessarily bad for YMI.
Fentora claims pain relief within 15 minutes.
Ymi claims aeroleaf relieves pain within seconds.

Fentora's approval validates the fast action for breakthrough pain as a valid goal, and aeroleaf is claimed to be far superior.

[DewDiligence]

Barr Launches Generic ACTIQ Cancer Pain Management Product

[As part of CEPH’s acquisition of Cima Labs in 2004, the FTC made CEPH agree to allow BRL to launch a generic version of Actiq (fentanyl on a lollipop) so that CEPH would not have monopoly control of the U.S. breakthrough-pain market. This transaction worked out perfectly for CEPH, as they now have Fentora to sell in place of branded Actiq—an excellent tradeoff because Fentora is clearly the better product.]

http://biz.yahoo.com/prnews/060927/nyw030.html?.v=74

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Wednesday September 27, 8:13 am ET

WOODCLIFF LAKE, N.J., Sept. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) announced that its subsidiary, Barr Laboratories, Inc., has today launched a generic version of Cephalon Inc.'s ACTIQ® (oral transmucosal fentanyl citrate) [C-II], 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, and 1600 mcg cancer pain management treatment product. Barr launched the product under the terms of a License Agreement previously granted to Barr by Cephalon in August 2004, pursuant to a Federal Trade Commission Order. The license grants Barr a non-exclusive right to sell a generic version of ACTIQ. Under the obligations of the agreement, Cephalon is currently supplying Barr with fentanyl citrate manufactured under Cephalon's New Drug Application (NDA), which Barr then has the right to sell and market. Barr's Abbreviated New Drug Application (ANDA) is currently under active review at the U.S. Food & Drug Administration (FDA).

"We are pleased that this patent settlement has enabled Barr to bring a more affordable, generic version of this critical pain management therapy to cancer patients earlier than otherwise would have been possible," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "By launching this product, under the agreements with Cephalon, we are able to bring an additional option to patients that require this unique therapy."

ACTIQ is indicated for the treatment of breakthrough cancer pain in opioid tolerant patients and has current annual sales of approximately $590 million, based on IMS sales data for the twelve months ended July 2006.

Barr filed its ANDA for ACTIQ containing a paragraph IV certification with the FDA in October 2004. The Company received notification of the application's acceptance for filing in December 2004. Following receipt of the notice from the FDA, Barr notified Cephalon, the NDA holder and patent owner. On January 20, 2005, Cephalon filed suit in the U.S. District Court in Delaware to prevent Barr from proceeding with the commercialization of its product. In February 2006, Barr and Cephalon entered into an agreement to settle the patent infringement dispute and filed a dismissal with the Court to conclude the litigation between the parties regarding ACTIQ.

Under two agreements with Cephalon, Barr was provided a license for ACTIQ that was due to become effective on the earliest to occur of the following: (i) FDA approval of Cephalon's FENTORA® product; (ii) September 5, 2006, if Cephalon did not receive an extension of exclusivity based upon the completion of pediatric studies for ACTIQ; or (iii) December 6, 2006. On September 25, 2006 Cephalon received approval for its FENTORA product. In addition, Cephalon has not received the pediatric extension for ACTIQ, resulting in Barr's license having become effective as of September 5, 2006. As a result, Barr has launched its generic ACTIQ product.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
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[DewDiligence]

CEPH’s Fentora Works in Back Pain

[CEPH paid a high price to acquire Fentora and they forewent sales of Actiq to seal the deal. Now we know why: Fentora was recently approved for cancer pain (#msg-13569581) and it appears to work well enough and fast enough to be used more generally. YMI’s AeroLEF could be the odd man out in this arena.]

http://biz.yahoo.com/prnews/061011/phw023.html?.v=76

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Cephalon Announces Positive Results for FENTORA(TM) (fentanyl buccal tablet) for Breakthrough Pain in Patients with Chronic Low Back Pain

Wednesday October 11, 9:24 am ET

FRAZER, Pa., Oct. 11 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) today announced that data from a Phase 3 clinical trial of FENTORA(TM) (fentanyl buccal tablet) [C-II] demonstrate efficacy in the management of breakthrough pain in opioid-tolerant patients with chronic low back pain.

In the double-blind, placebo-controlled study, statistically significant differences in pain intensity were apparent within 10 minutes (p<0.02) and at all subsequent time points measured throughout the 120 minute assessment period (p<0.0001). Improvement as measured on the primary endpoint (the Sum of Pain Intensity Differences at 60 minutes, SPID60) was also significant (p<0.0001). Adverse events were typical for opioids and more frequent during the titration phase than the double-blind phase.

Data from the Cephalon- sponsored study will be presented at upcoming medical meetings, including a poster presentation at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine, November 16-19, 2006, in San Francisco.

"The results of this study suggest that FENTORA may have application beyond its current indication in cancer and provide important support to our strategy for future label expansion in breakthrough pain associated with multiple chronic pain conditions," said Dr. Lesley Russell, Senior Vice President, Worldwide Medical and Regulatory Operations. "In opioid-tolerant patients, we believe FENTORA has the potential to address the rapid onset characteristic of breakthrough pain, a common component of low back pain." An estimated 51 percent of people with chronic pain report back pain, making it the most common chronic pain condition, according to the American Chronic Pain Association.

FENTORA

FENTORA was approved by the Food and Drug Administration on September 25, 2006, for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Its drug delivery system generates a reaction that is accompanied by transient changes in pH believed to optimize how well the tablet dissolves and how quickly the medicine passes across the lining of the cheek, or buccal mucosa. In clinical trials involving patients with cancer, FENTORA was generally well tolerated; most adverse events with FENTORA are typical opioid side effects and mild to moderate in severity. The most common (greater than or equal to 10%) adverse events observed in clinical trials of FENTORA were nausea, vomiting, application site abnormalities, fatigue, anemia, dizziness, constipation, edema, asthenia, dehydration, and headache. No attempt was made to correct for concomitant use of around-the-clock opioids or cancer-related symptoms. 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.

Breakthrough Pain

Breakthrough pain - a component of chronic pain - 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. An estimated 64 percent of all cancer patients treated for persistent pain - and an estimated 74 percent of patients treated for persistent pain from other chronic pain conditions - will experience breakthrough pain.

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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