Joint Press Release. Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. FAJARDO, Puerto Rico and BOSTON, Mass., July 9, 2007 - Xxxxxx Xxxxxxxx Company, Inc. and Paratek Pharmaceuticals, Inc. announced today that the two companies have entered into an exclusive license agreement for the development and commercialization of novel, narrow-spectrum tetracyclines for the treatment of acne and rosacea. Tetracycline antibiotics are the leading approved systemic treatments of moderate to severe inflammatory acne. Discovered decades ago as broad-spectrum systemic antibiotics, tetracyclines have been shown to be potent anti-acne agents. Paratek has utilized its expertise in chemistry to develop novel narrow-spectrum antibacterial tetracyclines with improved anti-inflammatory activity, tolerability and other properties for the next generation treatment of acne and rosacea. These compounds represent the first tetracycline-derived new molecular entities ever to be synthesized specifically as improved therapeutics for dermatologic diseases. “We look forward to a productive collaboration with Paratek as we work together to progress Paratek’s novel tetracycline products through the development process and into commercialization” said Xxxxx Xxxxxxxxxxxxx, Chief Executive Officer and President of Xxxxxx Xxxxxxxx. “We are pleased to announce our collaboration with Xxxxxx Xxxxxxxx, a proven leader in the development and commercialization of dermatology products,” said Xxxxxx X. Xxxx, M.D., Co-founder and Chief Scientific Officer of Paratek Pharmaceuticals. “For years, dermatologists have sought therapies with a more targeted spectrum of activity. While effective, currently marketed tetracyclines possess antibacterial activity against a broad number of organisms not associated with acne or rosacea, which can lead to adverse consequences such as resistance development among life-threatening bacteria and persistent side effects. Paratek’s proprietary compounds have been designed to circumvent these issues by better targeting the causative bacteria and retaining potent anti-inflammatory properties.” Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. Under the terms of the agreement, Xxxxxx Xxxxxxxx will assume responsibility for clinical development of the tetracycline derivative products and will have exclusive rights to market the products in the United States. Paratek received an up-front payment and will be eligible to receive additional payments upon achievement of certain development and regulatory approval milestones. Xxxxxx Xxxxxxxx will pay a royalty to Paratek on sales of any product under the agreement. The leading candidate under the agreement is in preclinical development and expected to enter clinical development in 2008. Xxxxxx Xxxxxxxx Company Inc. is a subsidiary of Xxxxxx Xxxxxxxx Limited (Nasdaq: WCRX).
Appears in 2 contracts
Samples: Collaborative Research and License Agreement (Paratek Pharmaceuticals, Inc.), Collaborative Research and License Agreement (Paratek Pharmaceuticals Inc)
Joint Press Release. Portions Contacts: The Medicines Company Alnylam Pharmaceuticals, Inc. Michael XxxxxxxlHead of this ExhibitGlobal Communicxxxxxx000-000-0000xxxxxxx.xxxxxxxx@xxxxxxxx.xxx Xxxxxxx XxxxxxxVice President, indicated by Investor Relations and Corporate Communications617-551-8207 Amanda Sxxxxxx (Xxxxx)Spectrum202-955-6222 x2597 DRAFT - Not for Release The Medicines Company and Alnylam Form Strategic Alliance to Develop and Commercialize RNAi Therapeutics Targeting PCSK9 for the xxxx “[***],” were omitted Treatment of Hypercholesterolemia The Medicines Company Obtains Exclusive Global License to Advance ALN-PCS RNAi Therapeutic Program Alnylam to Receive $25 Million in Upfront Payment in Addition to Milestone Payments and have been filed separately with the Secretary of the Commission pursuant Royalties on Product Sales Companies to the Registrant’s application requesting confidential treatment pursuant Host Conference Call Today at 8:30 a.m. ET to Rule 406 of the Securities Act of 1933Discuss Collaboration Parsippany, as amended. FAJARDO, Puerto Rico N.J. and BOSTONCambridge, Mass., July 9February 4, 2007 2013 - Xxxxxx Xxxxxxxx Company, Inc. The Medicines Company (Nasdaq: MDCO) and Paratek Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that the two companies they have entered into formed an exclusive license agreement global alliance for the development and commercialization of novel, narrowAlnylam's ALN-spectrum tetracyclines PCS RNAi therapeutic program for the treatment of acne hypercholesterolemia. “This new alliance unites two organizations with a shared culture and rosaceacommitment to innovation. Tetracycline antibiotics are In my view and past experience, there could be no stronger partner for our ALN-PCS program than The Medicines Company, which has demonstrated industry-wide leadership in the leading approved systemic treatments advancement of moderate cardiovascular medicines to severe inflammatory acnepatients and remarkable success in its strategy of in-licensing, developing, and commercializing breakthrough products,” said John Marxxxxxxx, Xx.X., Chief Executive Officer of Alnylam. Discovered decades ago as broad“For Alnylam, this new partnership enables the advancement of ALN-spectrum systemic antibioticsPCS, tetracyclines have been shown to be potent antian important program within our 'Alnylam 5x15' product development and commercialization strategy focused on RNAi therapeutics directed toward genetically validated targets. We believe that the ALN-acne agents. Paratek has utilized its expertise in chemistry to develop novel narrow-spectrum antibacterial tetracyclines with improved anti-inflammatory activity, tolerability and other properties PCS program holds great promise for the next generation treatment development of acne a significant therapeutic option for patients with hypercholesterolemia, and rosaceathat the unique mechanism of action for ALN-PCS could provide a differentiated and potentially best-in-class strategy for PCSK9 antagonism.” “Our focus on acute and intensive care medicine has led us to a leadership position with Angiomax and potentially with cangrelor in the management of patients in extreme risk as a consequence of the rupture of their vulnerable coronary artery plaque at and around the time of acute coronary syndromes. These compounds represent Meantime, we have made progress with MDCO-216 (ApoA-1 Milano), a turbocharged form of HDL-C ('good cholesterol') which has the first tetracycline-derived new molecular entities ever potential to be synthesized specifically as improved therapeutics for dermatologic diseasesmodify disease through reverse cholesterol transport,” said Clive Mexxxxxx, X.X., Ph.D., Chairman and Chief Executive Officer of The Medicines Company. “Now, this exciting collaboration with Alnylam leaders in their field of RNAi adds a second potentially disease modifying approach and more cutting edge technology to our portfolio. We have seen that PCSK9 gene silencing can substantially reduce LDL-cholesterol in patients and has epidemiological and disease mechanisms studies suggest this can further reduce the risks of the world's number one killer, coronary artery disease. Clearly we see the complementarity of approaches which increase 'good cholesterol' (HDL-C) and decrease 'bad cholesterol' (LDL-C). We look forward to working with our colleagues at Alnylam for whom we have the greatest respect and admiration based upon earlier collaborations particularly around Angiomax, which was invented by John Marxxxxxxx.” XCSK9 (proprotein convertase subtilisin/kexin type 9) is a productive collaboration protein that regulates low-density lipoprotein (LDL) receptor levels on hepatocytes; gain-of-function human mutations in PCSK9 are associated with Paratek as we work together hypercholesterolemia while loss-of-function mutations are associated with lower levels of LDL cholesterol and a reduced risk of cardiovascular disease. ALN-PCS is a PCSK9 synthesis inhibitor that reduces intracellular and extracellular levels of PCSK9 resulting in lowered plasma levels of LDL-C. MDCO-216 is a naturally occurring variant of a protein found in high-density lipoprotein, or HDL. It is a reverse cholesterol transport agent designed to progress Paratek’s novel tetracycline products through the development process and into commercialization” said Xxxxx Xxxxxxxxxxxxx, Chief Executive Officer and President of Xxxxxx Xxxxxxxx. “We are pleased to announce our collaboration with Xxxxxx Xxxxxxxx, a proven leader in the reduce atherosclerotic plaque burden development and commercialization thereby reduce the risk of dermatology products,” said Xxxxxx X. Xxxxadverse thrombotic events. Under this alliance, M.D., Co-founder The Medicines Company and Chief Scientific Officer of Paratek Pharmaceuticals. “For years, dermatologists have sought therapies with a more targeted spectrum of activity. While effective, currently marketed tetracyclines possess antibacterial activity against a broad number of organisms not associated with acne or rosacea, which can lead Alnylam intend to adverse consequences such as resistance development among life-threatening bacteria and persistent side effects. Paratek’s proprietary compounds have been designed to circumvent these issues by better targeting collaborate on the causative bacteria and retaining potent anti-inflammatory properties.” Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Secretary advancement of the Commission pursuant ALN-PCS program. Alnylam's ALN-PCS program includes ALN-PCS02 an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program while funded by The Medicines Company for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. The Medicines Company will then lead and fund development from Phase II forward and commercialize the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amendedALN-PCS program if successful. Under the terms of the agreement, Xxxxxx Xxxxxxxx The Medicines Company will assume responsibility for clinical make an upfront cash payment of $25 million to Alnylam. Alnylam may also receive potential development and commercial milestone payments of the tetracycline derivative products and will have exclusive rights up to market the products in the United States$180 million. Paratek received an up-front payment and Alnylam will be eligible to receive additional payments upon achievement of certain development and regulatory approval milestones. Xxxxxx Xxxxxxxx will pay a royalty to Paratek scaled double-digit royalties on global products sales of any product under ALN-PCS products. Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C. Results showed that administration of a single intravenous dose of drug, in the agreementabsence of concomitant lipid-lowering agents such as statins, resulted in statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of LDL-C of up to 50%. ALN-PCS02 was shown to be generally safe and well tolerated in this study and there were no serious adverse events related to study drug administration. Alnylam has also presented pre-clinical data from its ALN-PCSsc program 66 demonstrating potent knockdown of the PCSK9 target gene with an ED50 of less than 0.3 mg/kg after a single subcutaneous dose. “Cardiovascular disease remains the leading cause of mortality worldwide, with elevated LDL-C a major modifiable risk factor. New strategies are needed to dramatically and rapidly reduce LDL-C and prevent acute cardiovascular events that result from the rupture of cholesterol rich plaque when patients are at their most vulnerable,” said Daniel J. Xxxxx, X.X., professor of Medicine and chief, Division of Translational Medicine and Human Genetics, at the Perelman Xxxxxx of Medicine at the University of Pennsylvania. “As a key regulator of the LDL receptor, liver-expressed PCSK9 is one of the most important and best validated new targets in molecular medicine for the treatment of hypercholesterolemia. The leading candidate under ALN-PCS data generated to date are very encouraging and I look forward to continued clinical studies that highlight the agreement is in preclinical development and expected to enter clinical development in 2008. Xxxxxx Xxxxxxxx Company Inc. is a subsidiary unique mechanistic approach of Xxxxxx Xxxxxxxx Limited (Nasdaq: WCRX)PCSK9 synthesis inhibitors.”
Appears in 2 contracts
Samples: License and Collaboration Agreement (Medicines Co /De), License and Collaboration Agreement (Medicines Co /De)