By Lewis Krauskopf. ORLANDO, Fla, March 29 (Reuters) - A combination of Abbott Laboratories' (ABT) new TriLipix triglycerides medicine and a low dose of AstraZeneca's (AZN) Crestor cholesterol drug proved better than the individual pills in helping improve heart risk factors, researchers said.

The combination did significantly better at lowering bad LDL cholesterol and other blood fats called triglycerides, as well as raising levels of good HDL cholesterol in patients with complex lipid disorders.

The late-stage data presented on Sunday at the American College of Cardiology scientific meeting in Orlando will be part of the U.S. application for a fixed-dose combination pill of the two medicines, which the drugmakers expect to submit in the second half of 2009.

Statins such as Crestor that lower LDL cholesterol are among the most widely used prescription drugs in the world. But many of the patients with high cholesterol also have high triglycerides and low levels of good HDL cholesterol, raising heart risks.

"There is a significant benefit to combining the two treatments together," said Dr. Eli Roth, professor of clinical medicine at the University of Cincinnati College of Medicine and an investigator in the study. "You tend to correct the entire atherogenic profile."

The 760 subjects in the Phase III trial were randomized to the standard dose of TriLipix, also known as finofibric acid, 5 milligrams of Crestor, also called rosuvastatin, or a combination of both.

After 12 weeks of therapy, the combination lowered LDL by 28.7 percent compared with 4.1 percent with TriLipix alone. It cut triglycerides by 40.3 percent compared with 17.5 percent with just Crestor. The combination raised HDL by 23 percent compared with 12.4 percent with Crestor alone.

The results were considered highly statistically significant.

"The numbers are impressive," Roth said. "If you quizzed most physicians about what kind of changes they'd see, they would know the direction it would go but I don't think they would know the magnitude."

The combination also lowered levels of a key inflammation marker, known as C-reactive protein, by 28 percent, compared with 8.7 percent with only TriLipix, and 11.4 percent with Crestor alone.

There were no additional adverse events found in combining the two drugs than from the individual pills, Roth said.

"The combination is very safe," Roth said

The planned combination pill can make it easier for doctors to help patients stay on their medicines, where they otherwise might have to juggle multiple prescriptions.

"Having two medicines in a single pill tends to make compliance on the patient's part much better," Roth said.

Results of combination studies using higher doses of Crestor with TriLipix were presented last June. The combination involving 5 mg of Crestor will appeal to patients who have difficulty tolerating higher doses of statins, Roth said.

Approved by U.S. regulators in December, TriLipix is the successor to Abbott's blockbuster TriCor medicine. Both are in triglyceride lowering fibrate class of drugs, but unlike TriCor, TriLipix is approved for use with statins. Crestor is one of AstraZeneca's top-selling medicines. (Additional reporting by Bill Berkrot; Editing by Carol Bishopric)

HAMILTON, Bermuda, March 27 /PRNewswire-FirstCall/ -- Warner Chilcott Limited (WCRX) announced today that its affiliate, Warner Chilcott Company Inc. has submitted a New Drug Application for WC 3016, a low-dose oral contraceptive, to the U.S. Food and Drug Administration.

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the U.S. pharmaceuticals market. The Company is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products.

BOSTON, March 26 (Reuters) - Amylin Pharmaceuticals Inc (AMLN.O) said on Thursday it is on track to file for regulatory approval of an extended-release version of its diabetes drug Byetta by the end of the second quarter.

Amylin and its partners Eli Lilly & Co (LLY.N) and Alkermes Inc (ALKS.O) said they have successfully shown that batches of the drug made by Amylin for commercial use are the same as batches made by Alkermes for use in clinical trials.

The companies also said an analysis of clinical trial databases showed no increased risk of heart-related side effects in patients taking standard Byetta, which is also known as exenatide. The long lasting version of Byetta is known as Byetta LAR.

"Both the manufacturing comparability data and the meta-analysis of the exenatide clinical trial database are key components of our submission," said Orville Kolterman, senior vice president of research and development at Amylin. "We believe that the material made at commercial scale is comparable to the clinical-scale material, and we are confident that we will have a strong submission package for exenatide once weekly."

WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC - News), a medical device company and a leader in surgical cardiac ablation, today announced that its new innovative disposable cryoablation system, Cryo1, received 510(k) clearance from the Food and Drug Administration, or FDA, for the cryosurgical treatment of cardiac arrhythmias.

Additionally, the first patient was successfully treated using the Cryo1 system by Dr. Niv Ad, the Chief of Cardiac Surgery at Inova Fairfax Hospital Department of Cardiovascular and Thoracic Surgery in Falls Church, Virginia. Dr. Ad, an internationally recognized thought leader in the field of cardiac surgery and the surgical treatment of cardiac arrhythmias, successfully used the AtriCure Frigitronics CCS-200 console and the Cryo1 linear disposable ablation probe to perform a minimally invasive, sole therapy cardiac ablation procedure.

The Cryo1 system offers several important benefits, including a long, malleable yet rigid design to achieve consistent contact, superior thermal dynamics and an active defrost mode which increases ease of use. In addition, the AtriCure Frigitronics CCS-200 console supports both our Cryo1 disposable probe and our well-established line of reusable cryoablation probes. The Frigitronics CCS-200 console and reusable probes have a strong market presence and a documented track record of safety and efficacy resulting from more than thirty years of use in cardiac arrhythmia procedures.

“The design and capabilities of the Cryo1 probe build on the high performance of the AtriCure Frigitronics platform. During this initial case we took advantage of the system’s unique capability to use reusable and disposable cryothermy ablation probes during the same procedure,” said Dr. Ad. “The active defrost function and the probe rigidity made the Cryo1 probe easy to use. This is a promising new technology and we look forward to further use and evaluation of the system.”

“The commercial release of our Cryo1 system further positions AtriCure as the leader in the surgical markets for cardiac ablation products. AtriCure is now the only cardiac surgical ablation company marketing a series of cryothermy and bipolar radiofrequency ablation systems combined with an innovative portfolio of enabling tools and mapping products,” said David J. Drachman, President and Chief Executive Officer. “We are excited to offer this new innovative technology solution which we believe will lead to market share gains and demonstrates our continued commitment to developing innovative technologies.”

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator^® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator^® system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has cleared the AtriCure Isolator^® system, including its Isolator Synergy^TM ablation clamps, and AtriCure’s multifunctional pen and Coolrail^TM linear ablation device, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF. AtriCure’s left atrial appendage clip system has not been approved for commercial use.

By Susan Heavey. WASHINGTON, March 27 (Reuters) - It is difficult to tell how well brain cancer patients responded to Genentech Inc's cancer drug Avastin in early studies from the company, U.S. Food and Drug Administration staff said in documents released on Friday.

In patients who saw an effect on their tumors, it was also unclear whether that was from the effect of Avastin or from other issues, the staff said, adding that the agency would seek advice from its panel of outside experts.

The documents were released ahead of the advisory panel's meeting on Tuesday.

* FDA staff cites issues with Genentech's Avastin data

* Genentech: data support use of drug for brain cancer

* FDA advisory panel to review possible new use Tues. 3/31/09

Genentech, now part of Roche (RHHBY.PK), is seeking accelerated U.S. approval to market its drug more widely for brain cancer patients with glioblastoma -- an especially deadly tumor -- who have already received other treatment. Avastin, also known as bevacizumab, is approved for lung, colon and breast cancers.

Malignant brain tumors are one of the deadliest types of cancer and have seen renewed public attention since Senator Edward Kennedy was diagnosed last year. Patients on average survive six to 12 months after diagnosis, or six months without treatment.

Glioblastomas are the most aggressive type of brain tumor, killing about 10,000 people each year. Other treatments include chemotherapy and radiation.

In separate documents released on Friday, Genentech said its data showed improvements in patients with brain cancer and that it was starting a larger study that would offer more information in 2014.

"There are no effective FDA-approved systemic therapies for patients with previously treated glioblastoma, and there have been virtually no improvements since the 1970s," the company said.

Avastin is a type of anti-angiogenic drug that restricts the rapid growth of blood vessels that spur tumor growth.

One study of 167 patients found a median response rate of 4.2 months among those who saw a tumor reduced, while a second study of 56 patients found a median response of 3.9 months, according to the FDA.

The most common side-effects were fatigue, headache and hypertension, although none seemed significant, the FDA said.

Avastin saw U.S. net sales of $2.7 billion in 2008. Some 19,000 cases of brain tumors are diagnosed each year, the company has said, citing government statistics.

Shares of Roche, which completed its acquisition of Genentech on Thursday, were up more than 2 percent on the Swiss market.

COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ: OSIR - News) announced today that it has elected to end enrollment at 210 patients in its Phase III trial evaluating Prochymal for Crohn’s disease. The Company believes there is a design flaw in the trial resulting in significantly higher than expected placebo response rates. The decision was made after the trial’s final scheduled interim analysis showed that one of the two Prochymal dose arms had crossed a futility boundary. The dose arm was unlikely to achieve the primary endpoint of remission because of the high placebo response rate. This latest analysis continued to show no serious safety concerns with the therapy and safety was not a factor in the decision to stop enrollment.

C. Randal Mills, Ph.D. President and CEO of Osiris Therapeutics said, “We had a situation where we were experiencing much higher than expected placebo response rates. As we looked into possible causes, we discovered what we believe to be a systemic design flaw in the trial that would likely affect the utility of the data for purposes of registration. After careful discussion with the FDA, we elected to discontinue enrollment rather than attempt to re-power the trial. We will keep the trial blinded and expect a solid data package for use in designing future trials in Crohn’s disease and to bolster Prochymal’s safety database.”

Mills continued, “I would like to personally thank the physicians, study professionals, and of course the patients who have dedicated their time to this trial, and appreciate their ongoing participation.”

The Prochymal Crohn’s program consists of two separate but related double blinded trials. The first trial evaluates patients’ initial response to two dose levels of Prochymal as compared to placebo. The trial was originally designed to enroll 270 subjects. The potential trial design flaw may be related to the fact that patients responding to the initial therapy were eligible to participate in a second, longer-term trial evaluating Prochymal as a maintenance therapy. Because the current standard for determining response of Crohn’s patients to therapy is largely subjective, there may have been response bias to meet the eligibility requirements for continuation of therapy in the longer-term maintenance trial.

David Meeker, M.D., Executive Vice President at Genzyme Corporation said, “We fully agree with the decision by Osiris to end enrollment in this trial due to what appears to be a problem with the trial design. We think this is prudent and will enable a more efficient path forward. The data from this trial will be extremely valuable in designing the subsequent trial and enabling the continued development of this first-in-class therapy.”

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dyax Corp. (NASDAQ:DYAX - News) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) pertaining to the Company’s Biologic License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE). The letter outlines requirements for approval of DX-88 in this indication. Specifically, the FDA has requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. The letter does not include requirements for any additional clinical trials for approval of DX-88.

Dyax intends to fully address the FDA’s requests in a timely manner. Dyax previously submitted to the FDA a proposed Safe Use program, which Dyax will now be converting into a REMS as part of its response. The CMC questions are primarily focused on analytical methodologies and specifications and validation activities in support of drug product filling and packaging. Earlier this year, a pre-approval inspection of the manufacturing processes, sites and supporting quality systems was successfully completed.

Upon receipt of the Company’s response, the FDA will determine a revised review period based on guidelines defined in the Prescription Drug User Fee Act (PDUFA) and notify Dyax of when it expects to render a decision on the approvability of DX-88.

“Dyax’s clinical, regulatory and manufacturing groups have already begun work on providing all necessary information to complete the BLA approval process,” said Gustav A. Christensen, President and Chief Executive Officer of Dyax. “We will continue to work with the FDA to ensure that DX-88 will be available to patients suffering from this rare, potentially fatal genetic disorder as quickly as possible.”

About DX-88 for HAE

The recombinant, small protein, DX-88 (ecallantide), was discovered utilizing Dyax's proprietary phage display technology. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and is being evaluated as a subcutaneous therapy for treating acute HAE attacks.

About HAE

Hereditary angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood.

IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI - News) announced today that it received notification that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for FUSILEV™ (levoleucovorin) for Injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009.

The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. In December 2008, FUSILEV was listed in the National Comprehensive Cancer Network^® (NCCN) Drugs and Biologic Compendium™ to be used in combination with high-dose methotrexate for the treatment of bone cancer (osteosarcoma and dedifferentiated chrondrosarcoma), and the NCCN Clinical Practice Guidelines in Oncology™ in Colon Cancer and Rectal Cancer were updated to reflect that FUSILEV is available in the United States.

About FUSILEV™ (levoleucovorin) for Injection

FUSILEV, a novel folate analog, is available in vials as freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.

Full prescribing information can be found at www.fusilev.com.

About NCCN

The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

World-renowned experts from NCCN Member Institutions diagnose and treat patients with a broad spectrum of cancers and are recognized for dealing with complex, aggressive, or rare cancers. More than 160,000 new patients receive cancer care at NCCN Member Institutions over the course of any year. NCCN Member Institutions pioneered the concept of the multidisciplinary team approach to patient care and lead the fight against cancer as they integrate programs in patient care, research, and education. Our programs offer access to expert physicians, superior treatment, and quality and safety initiatives that continuously improve the effectiveness and efficiency of cancer care. Thirty-seven Nobel Prize winners have served on the faculties of NCCN Member Institutions.

Mylan and Alphapharm Pty. Ltd were sued by Sepracor Inc. in the U.S. District Court of New Jersey in connection with the ANDA filing for Eszopiclone Tablets, 1 mg, 2 mg and 3 mg. Eszopiclone Tablets are the generic version of Sepracor's insomnia treatment Lunesta(R) Tablets, which had approximately $796 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals Inc. was sued by OSI Pharmaceuticals Inc., Pfizer Inc. and Genentech Inc. in the U.S. District Court in Delaware in connection with the ANDA filing for Erlotinib Hydrochloride (HCl) Tablets, 25 mg, 100 mg and 150 mg. Erlotinib HCl Tablets are the generic version of OSI Pharmaceuticals' lung cancer treatment Tarceva(R) Tablets, which had approximately $492 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan, Mylan Pharmaceuticals and Matrix Laboratories Limited, in which Mylan owns a majority interest, were sued by Shire Canada Inc., Shire International Licensing B.V. and Shire U.S. Inc. in the U.S. District Court for the Southern District of New York in connection with the ANDA filing for Lanthanum Carbonate Chewable Tablets, 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets are the generic version of Shire's kidney disease treatment Fosrenol(R), which had approximately $108 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan Pharmaceuticals was sued by Galderma Laboratories Inc., Galderma Laboratories LP, The Research Foundation of the State University of New York and New York University in the U.S. District Court of Delaware in connection with the ANDA filing for Doxycycline Delayed-release (DR) Capsules USP, 40 mg. Doxycycline DR Capsules are the generic version of Galderma's adult rosacea treatment Oracea(R) Capsules, which had approximately $82 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.

Mylan believes it is among the first companies to have filed substantially complete ANDAs containing a Paragraph IV certification for three of these products and expects to be awarded 180 days of shared marketing exclusivity once final approvals are obtained. With Doxycycline DR Capsules, Mylan believes it could have sole marketing exclusivity for the 180 day period. Currently, Mylan has 118 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.

This press release includes statements that constitute "forward-looking statements," including with regard to the expected first to file status and pending litigation. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.