Tessera Technologies (TSRA), Micron (MU) Enter Patent, Tech Licensing Agreements Jul 30, 2014 05:03PM

Tessera Technologies (Nasdaq: TSRA) and Micron Technology, Inc. (“Micron”) (Nasdaq: MU) announced today the execution of new, multiyear technology and patent license agreements. In addition to the new patent license agreement, Tessera’s wholly-owned subsidiary Invensas Corporation will license its Multi-Die Face-Down (xFDTM) semiconductor packaging technology to Micron and cooperate with Micron on the manufacturing of Micron products that incorporate xFD technology. As part of the agreements, Tessera and Micron will also explore other possible joint development efforts.

Tessera’s Chief Executive Officer Tom Lacey praised the agreements. “We are delighted to reach new long-term agreements with Micron that build on our existing relationship. We are thrilled to be working closely with one of the most successful and innovative semiconductor companies on the planet,” Lacey said. “We have continued to develop innovative, next-generation technologies that we seek to commercialize with world-class partners like Micron. We look forward to working with Micron to commercialize high performance multi-chip xFD DRAM and other products.”

“We are pleased to reach agreement with Tessera, including a patent license and a technology agreement relating to Tessera’s xFD packaging technology,” said Mark Durcan, Micron’s Chief Executive Officer. “We look forward to discussing further joint development opportunities with Tessera.”

The specific terms and conditions of the agreements are confidential and have not been disclosed by the companies.

BioMarin (BMRN) Tops Q2 EPS by 18c, Sells riority Review Voucher for $67.5 Million Jul 30, 2014 04:56PM

BioMarin Pharmaceuticals, Inc. (NASDAQ: BMRN) reported Q2 EPS of ($0.23), $0.18 better than the analyst estimate of ($0.41). Revenue for the quarter came in at $191.8 million versus the consensus estimate of $159.7 million.

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that it has sold the Rare Pediatric Disease Priority Review Voucher (PRV) it obtained in February of this year. The Company received the voucher under an FDA program intended to encourage the development of treatments for rare pediatric diseases. BioMarin was awarded the voucher when it received approval of VIMIZIM®, a new biological product for patients with Mucopolysaccharidosis type IVA, also known as Morquio A syndrome. BioMarin received $67.5 million from Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, Inc., in exchange for the voucher.

For earnings history and earnings-related data on BioMarin Pharmaceuticals, Inc. (BMRN) click here.

Yum! Brands, Inc. (YUM) Terminates Relationship with OSI; Notes Significant, Negative Impact to Same-Store Sales from News Coverage Jul 30, 2014 04:18PM

Yum! Brands, Inc. (NYSE: YUM) is providing the following statement:

On July 20th, an undercover report was televised in China depicting improper food handling practices by supplier Shanghai Husi, a division of OSI. Subsequently, the Shanghai FDA launched an investigation into this matter, alleging illegal activity. Upon learning of this, we immediately terminated our relationship with OSI globally, with minimal disruption to our menu offerings in China.

While OSI was not a major supplier to Yum! Brands, these events triggered extensive news coverage in China that has shaken consumer confidence, impacted brand usage, and disparaged the hard work of our over 400,000 Chinese employees. The result has been a significant, negative impact to same-store sales at both KFC and Pizza Hut in China over the past 10 days. Yum! Brands is outraged by the alleged illegal activity by Shanghai Husi and its violations of our standards. We reserve the right to take full legal action for the impact this has had to our business once the Shanghai FDA investigation is complete.

At this point, it is too early to know how quickly sales will rebound in China and the corresponding full-year financial impact to Yum! Brands. However, if the significant sales impact is sustained, it will have a material effect on full-year earnings per share. We will provide additional perspective on this matter during our third-quarter earnings call in October. Our brands have proven resilient over time and we expect this to be the case with this situation as well.

Dendreon Corp (DNDN) Names Thomas Amick as CEO Jul 30, 2014 04:05PM

Dendreon Corporation (Nasdaq: DNDN) today announced that its board of directors has appointed W. Thomas Amick as president and chief executive officer, effective immediately. Mr. Amick has also been appointed to the Company’s board of directors. Mr. Amick succeeds John H. Johnson, who previously announced his plans to step down as president and chief executive officer for personal reasons. Mr. Johnson will work with Mr. Amick through August 15, 2014 to ensure a smooth transition.

Mr. Amick brings to Dendreon significant experience within the pharmaceutical and life sciences industry. Most recently from 2010 to 2012, he served as chairman and chief executive officer of Discovery Labs, a specialty biotechnology company. Under his leadership, Discovery Labs was granted approval for Surfaxin, the first synthetic lung surfactant approved for use in premature infants. Prior to that, Mr. Amick enjoyed a highly successful 30-year career with Johnson & Johnson where, as vice president of the Ortho Biotech Oncology Franchise, he launched Procrit® (epoetin alfa) and built J&J’s oncology franchise into a multi-billion dollar operation, making Procrit the most successful product in J&J history at the time. Mr. Amick also previously held positions as president of Ortho Biotech Europe, president of Janssen-Ortho Canada, and vice president of J&J Development Corporation (the venture capital division of J&J).

“Tom’s appointment is the result of a thorough search process,” said Douglas G. Watson, chairman of the board. “We believe that Tom’s leadership experience and oncology product expertise make him an excellent fit for Dendreon.”

“I have a great passion and respect for Dendreon’s mission of transforming the lives of patients through the discovery, development and commercialization of innovative cancer treatments,” said Mr. Amick. “I believe that PROVENGE is a unique immunotherapy treatment and look forward to working with the Dendreon team.”

Regeneron (REGN) and Sanofi (SNY) Report Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission Jul 30, 2014 04:02PM

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NYSE: SNY) today announced that the Companies intend to use a U.S. Food and Drug Administration (FDA) rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited 6-month review from the filing date instead of the standard 10-month review.

Regeneron Ireland, an indirect, wholly-owned subsidiary of Regeneron Pharmaceuticals, Inc., purchased the voucher from BioMarin GALNS Ltd., a direct, wholly-owned subsidiary of BioMarin Pharmaceutical, Inc., which had received it through the FDA's Rare Pediatric Disease Priority Review Voucher Program. Sanofi and Regeneron will equally share the purchase price of $67.5 million.

"The priority review voucher program was established to provide incentives that would enhance innovation in key areas of unmet patient need," said Ned Braunstein, M.D., Vice President, Regulatory Affairs at Regeneron. "Our decision to acquire and leverage the voucher is clear evidence that this program is a valuable incentive for biopharmaceutical companies."

Sanofi and Regeneron expect to submit U.S. and EU regulatory submissions for alirocumab before year end. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is being evaluated for its potential to lower low-density lipoprotein cholesterol (LDL-C) in patients who are not at their current LDL-C target with standard lipid-modifying therapies.

The Pediatric PRV was created by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) and is intended to encourage the development of treatments for rare pediatric diseases. Companies that receive a voucher may use it or transfer the voucher, including by sale, to other organizations.

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