GuruTrader
15 years ago
Cephalon Signs Option Agreement to Acquire BioAssets Development Corporation
Deal will Provide Cephalon New Path Forward for Development of its Tumor Necrosis Factor Inhibitor
Press Release
Source: Cephalon, Inc.
On 8:22 am EDT, Monday October 26, 2009
Buzz up! 0 Print.Companies:Cephalon Inc.
FRAZER, Pa. and WELLESLEY, Mass., Oct. 26 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) and BioAssets Development Corporation (BDC), a privately held biopharmaceutical company, today announced that the companies have signed an agreement that will provide Cephalon with an option to acquire BDC. Under the terms of the option agreement, Cephalon will pay BDC an upfront payment of $30 million and, assuming exercise of the option, an additional payment on the closing of the acquisition. BDC stockholders could also receive additional future payments related to regulatory and sales milestones. The option agreement is subject to customary closing conditions including the receipt of necessary BDC stockholder approvals.
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CEPH 53.92 0.00
{"s" : "ceph","k" : "c10,l10,p20,t10","o" : "","j" : ""} BDC is currently conducting a Phase two placebo-controlled proof of concept study with the tumor necrosis factor (TNF) inhibitor, etanercept, epidurally administered to a minimum of 40 patients with sciatica. Sciatica is a neuropathic inflammatory pain condition that occurs when the sciatic nerve is compressed, injured or irritated. BDC has secured an intellectual property estate around use of TNF inhibitors for sciatic pain in patients with intervertebral disk herniation, as well as other spinal disorders.
"BioAssets offers an estate of intellectual property and scientific expertise that will allow us to evaluate our own domain antibody tumor necrosis factor inhibitor, CEP-37247 (formerly known as ART-621), for the treatment of sciatica," said Frank Baldino, Jr., Ph.D. chairman and CEO of Cephalon. "Combining these two innovations helps fulfill our strategy to address unmet patient needs, while focusing on specialty physicians."
"Development of an improved non-surgical therapy for sciatica presents a pressing unmet medical need and a potentially significant commercial opportunity," commented James Gorman, M.D., Ph.D., CEO of BioAssets. "Cephalon combines an innovative TNF inhibitor pipeline with a well established pain therapeutic franchise. I believe these capabilities uniquely position Cephalon to develop and commercialize a novel biologic therapy for these patients."
Cephalon may exercise its option at any time from the closing date of the option agreement until the date that is 60 days after receipt of one-month patient response data from the Phase two proof of concept study. Data are anticipated to be available in the second half of 2010.
The Cephalon pipeline of pain products includes intravenous celecoxib and two tamper-deterrent opioid medications. Earlier this year, Cephalon completed the acquisition of Arana Therapeutics and added to its pipeline several domain antibody biologics targeted to inflammatory diseases and cancer. One of those compounds CEP-37247 (formerly known as ART-621) is a tumor necrosis factor inhibitor. The complete Cephalon pipeline can be viewed at http://www.cephalon.com/our-science/pipeline/.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, 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 has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key affiliates are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company's proprietary products in the United States include: NUVIGIL® (armodafinil) Tablets [C-IV], TREANDA® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), PROVIGIL® (modafinil) Tablets [C-IV], and ACTIQ® (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855 1-800-896-5855.
About BioAssets Development Corporation
BioAssets Development Corporation is a private company pioneering novel spine indications for emerging and marketed biologic drugs. The Company's lead initiative focuses on the development of a TNF inhibitor therapy to treat the underlying cause of pain in sciatica. For more information, visit www.biodevco.com.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon's current expectations or forecasts of future events. These may include statements regarding whether Cephalon ultimately will acquire BDC, anticipated scientific progress on its research programs, development of potential pharmaceutical products such as an anti-TNF reactor agent, the relative value to Cephalon's business and the effect on Cephalon's long-term growth of biologic products and the possible acquisition of BDC, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" or other words and terms of similar meaning. Cephalon's performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion
Contacts:
Cephalon:
Media: Investor Relations:
Sheryl Williams Chip Merritt
610-738-6493 610-738-6493 (office) 610-738-6376 610-738-6376 (office)
610-457-5257 610-457-5257 (cell) cmerritt@cephalon.com
swilliam@cephalon.com
BDC:
Media: Investors:
Douglas MacDougall James Gorman
President CEO & President
MacDougall Biomedical BioAssets Development
Communications Corporation
781-235-3060 339-686-2000
dmacdougall@macbiocom.com jgorman@biodevco.com
surf1944
16 years ago
Journal of Clinical Oncology Publishes Study of Cephalon Medication TREANDA Plus Rituximab in Relapsed Non-Hodgkin's Lymphoma
Tuesday July 15, 8:44 am ET
Study Reports 92 Percent Response Rate to Combination Treatment
FRAZER, Pa., July 15 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) announced today that in a phase 2 study published online today in the Journal of Clinical Oncology, 92 percent of patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma (NHL) responded to treatment with TREANDA® (bendamustine hydrochloride) for Injection plus rituximab. This combination study is one of three studies in patients with NHL that Cephalon submitted in December 2007 to the U.S. Food and Drug Administration requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. TREANDA was approved by the FDA in March 2008 for the treatment of patients with chronic lymphocytic leukemia and is not currently approved for use in NHL.
"A variety of treatment options have been employed in patients with indolent B-cell and mantle cell lymphomas, but resistance to treatment in this patient population often limits effective therapeutic options," said Dr. Charles Morris, Vice President, Worldwide Clinical Research at Cephalon. "Based on what we saw in this study, the combination of TREANDA with rituximab appears to elicit a high rate of durable responses and encouraging progression-free survival."
About the Study
In this multi-center, open-label, single arm, Phase 2 study, 66 patients with relapsed, indolent B-cell or mantle cell lymphoma without documented resistance to prior rituximab therapy were treated. Patients received rituximab 375 mg/meter squared intravenously on day one and TREANDA 90 mg/meter squared intravenously on days two and three of a 28-day cycle for up to six cycles. An additional dose of rituximab was given one week before the first cycle and four weeks after the last cycle.
Overall response rate was 92 percent with a complete response rate (CR) of 41 percent. A CR means that after treatment with the TREANDA and rituximab combination, patients had no detectable evidence of disease. These responses were durable, with a median duration of 21 months overall (19 months for the mantle cell population). Additionally, the combination of TREANDA and rituximab was associated with progression-free survival (PFS) of 23 months overall and for patients with mantle cell lymphoma.
In this published study, the combination of both treatments was generally well tolerated. The most common adverse events in the trial included myelosuppression (a condition in which bone marrow activity is decreased), nausea, infection, fatigue, constipation, and diarrhea.
This combination study is one of three studies in patients with NHL that Cephalon submitted to the FDA in December 2007 requesting approval of TREANDA for the treatment of patients with indolent NHL who have progressed during or following treatment with rituximab or a rituximab-containing regimen. The other two studies evaluated the efficacy and safety of TREANDA as monotherapy in this patient population. In all three studies, patients treated with TREANDA had a high rate of response and a manageable side effect profile, with myelosuppression as the most common side effect. Cephalon anticipates a review decision on this application by the agency by October 31, 2008.
surf1944
17 years ago
Cephalon Announces FDA Advisory Committee Recommendation Against Approval of an Expanded Label for FENTORA
Tuesday May 6, 5:49 pm ET
Cephalon to Hold Conference Call with Investors Today at 5:30 p.m. EDT
FRAZER, Pa., May 6 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH - News) announced today that a Joint Advisory Committee to the U.S. Food and Drug Administration (FDA) voted not to recommend approval of an expanded label for FENTORA® (fentanyl buccal tablet) [C-II] for the management of breakthrough pain in opioid-tolerant patients with chronic pain conditions. The panel expressed concerns about minimizing risks potentially associated with an expanded indication of FENTORA. During the meeting, the company presented a comprehensive and novel Risk Minimization Action Plan (RiskMAP) to address these risks.
FDA action on the FENTORA supplemental new drug application (sNDA) is expected by September 13, 2008. FENTORA is currently indicated for the management of breakthrough pain in opioid-tolerant patients with cancer.
"We are disappointed with the recommendation of the Advisory Committee," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations at Cephalon. "We will work with the FDA over the next few months to determine future steps including any additional risk minimization strategies that could potentially address the panel's concerns in this broader patient population."
The recommendation of the Joint Advisory Committee for Anesthetic and Life Support Drugs and the Advisory Committee for Drug Safety and Risk Management was based upon data presented by Cephalon from three randomized clinical trials and one 18-month open-label safety study with a total of 941 patients. The Joint Advisory Committee also considered proposed enhancements to the FENTORA RiskMAP that are designed to assure appropriate patient selection and to mitigate the risks of overdose, abuse, and diversion.
The FDA considers the Committee's recommendation in its review of the sNDA for FENTORA, which was submitted by Cephalon in November 2007. The FDA is not required to follow the Committee's guidance, but the agency does take this advice into consideration when reviewing a proposed label expansion.
Conference Call for Investors
Cephalon management will discuss the FDA Advisory Committee proceedings with investors during a conference call beginning at 5:30 p.m. EDT today. To participate in the conference call, dial 1-913-312-0407 and refer to conference call ID number 2046179. Individual investors are encouraged to log onto the investor relations section of http://www.cephalon.com and click on the webcast to access the live call.
PHYSICIANS AND OTHER HEALTHCARE PROVIDERS MUST BECOME FAMILIAR WITH THE IMPORTANT WARNINGS IN THIS LABEL.
Reports of serious adverse events, including deaths in patients treated with FENTORA have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of FENTORA for any other fentanyl product may result in fatal overdose.
FENTORA is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid daily for a week or longer.
FENTORA is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.
FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.
When prescribing, do not convert patients on a mcg per mcg basis from ACTIQ to FENTORA. Carefully consult the Initial Dosing Recommendations table. (See DOSAGE AND ADMINISTRATION, Table 7.)
When dispensing, do not substitute a FENTORA prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of FENTORA for any other fentanyl product may result in fatal overdose.
Special care must be used when dosing FENTORA. If the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY one additional dose using the same strength and must wait at least 4 hours before taking another dose.(See DOSAGE AND ADMINISTRATION.)
FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
The concomitant use of FENTORA with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.
Carefully consult the Initial Dosing Recommendations table. (See DOSAGE AND ADMINISTRATION, Table 7.)
When dispensing, do not substitute a FENTORA prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of FENTORA for any other fentanyl product may result in fatal overdose.
Special care must be used when dosing FENTORA. If the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY one additional dose using the same strength and must wait at least 4 hours before taking another dose.(See DOSAGE AND ADMINISTRATION.)
surf1944
17 years ago
FDA panel rejects Cephalon pain drug on risks of misuse
Tuesday May 6, 4:59 pm ET
By Matthew Perrone, AP Business Writer
FDA panel votes against wider approval for Cephalon pain pill, citing risks for abuse
WASHINGTON (AP) -- Medical experts on Tuesday voted against allowing a powerful painkiller made by Cephalon Inc. to be marketed for uses beyond treating pain in cancer patients, saying it could worsen existing misuse of the drug that has caused overdoses and death.
Cephalon's drug Fentora is already approved to treat severe pain flare-ups in cancer patients already taking opioids, a type of prescription painkiller. The company wants Food and Drug Administration approval to market the drug for chronic pain not caused by cancer, a broader market that includes patients with back and nerve pain.
An FDA panel of outside experts voted 17-3 against wider use of the drug. The agency is not required to follow the panel's advice, though it usually does.
Panelists questioned the need for such a powerful pain medication for noncancer patients, given narcotics already on the market.
"How many people are we going to help with the release of this product and how many are we going to hurt?" asked panel member Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh. "In my mind it is very scary to release such a large amount of powerful opiate into the American population."
FDA scientists said Tuesday that widening approval of the drug could have dangerous effects because of the risks for improper prescribing and abuse of the drug, which is more potent than other pain medications.
Fentora was approved in 2006 under strict guidelines meant to ensure it was only used by cancer patients already taking other opioid drugs for pain. Since then, FDA said prescriptions for the drug have increased fivefold, with more than 80 percent of patients taking the drug "off-label," or for unapproved uses.
Doctors are allowed to prescribe medications for off-label uses, though companies cannot promote them.
Cephalon has reported five patient deaths due to negative reaction or overdose on the drug.
The company argued that since Fentora is already being prescribed for unapproved uses, expanding its FDA-approved indication would help ensure it is being used safely.
Currently about 20,000 U.S. patients take the drug. Panelists said expanding its use to noncancer patients could broaden use to more than 10 million patients.
Panelists praised a new plan proposed by Cephalon that would require pharmacists to electronically confirm a patient's symptoms before dispensing the drug.
"The company is doing the responsible thing to do when you find out your drug is only treating 20 percent of patients it's intended for, and being used off-label 80 percent of the time," said Frank Vocci, director for drug abuse at the National Institutes of Health.
Most panelists said, however, that the company must perform more studies to prove its plan will help reduce medication errors and abuse of the drug.
Fentora is part of the opioid class of prescription painkillers, which also includes morphine and codeine. The drugs can be highly addictive and are sometimes abused for their euphoric effects, which are similar to those of heroin.
Because Fentora is more potent than other opioids, the FDA said it could be more attractive -- and dangerous -- to potential abusers.
But Cephalon rejected this notion, pointing to studies by Columbia University researchers that showed its drug was no more attractive to heroin addicts than other narcotics.
FDA is expected to make its final decision on the drug by mid-September.
Even if FDA rejects Cephalon's request, analysts do not expect it to significantly harm the company's earnings outlook. Fentora accounted for just 8 percent of the company's total revenue last year, or $137 million.
Friedman, Billings, Ramsey analyst David Amsellem expects Fentora to grow to $161 million by 2012, but remain at 8 percent of the company's total sales. Most of the company's recent growth has come from sales of its narcolepsy drug, Provigil, which accounted for half of its 2007 revenue.
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