Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus (AAV) gene therapies. 
  

Under the terms of the agreement Sangamo will issue to the stockholders of Ceregene 100,000 shares of Sangamo's common stock, which represents less than 0.2% of Sangamo's total shares outstanding.  In addition, Sangamo has agreed to make contingent earn-out payments to the stockholders of Ceregene based upon revenues generated from license or sales transaction of certain existing products of Ceregene. The acquisition is expected to close in September 2013, subject to customary closing conditions. 
  

Sangamo will receive over 120 issued, pending or in-licensed patents that include patent families covering the AAV vector platform and manufacturing methods, therapeutic transgenes, and technology for direct administration of AAV to the brain.  Sangamo will also have access to GMP master cell banks, materials and manufacturing know-how that will expand its capabilities in AAV manufacturing as well as a database of preclinical efficacy and toxicology studies and other documentation supporting Ceregene's Investigational New Drug (IND) applications.  

These materials provide reference materials for Sangamo in the preparation and filing of IND applications for its in vivo ZFP Therapeutics, particularly those that target the brain. ZFP Therapeutics is the proprietary name for the company's DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs).  Engineering of ZFPs that recognize a specific DNA sequence enables the creation of sequence-specific ZFP nucleases for gene modification and ZFP transcription factors that can control gene expression and, consequently, cell function. Sangamo has entered into a strategic collaboration with Shire to develop therapeutics for hemophilia, Huntington's disease and other monogenic diseases and has established strategic partnerships with companies in non-therapeutic applications of its technology including Sigma-Aldrich. 

In addition, Sangamo will acquire all of Ceregene's preclinical and clinical therapeutic programs, the Phase II  trial to evaluate Ceregene's CERE-110 in Alzheimer's disease and the proprietary needle device for brain delivery of AAV with supporting regulatory documentation and clinical experience. CERE-110 is an AAV vector that carries the gene for NGF, a naturally occurring protein that maintains survival of nerve cells in the brain. 


Articles

Sangamo BioSciences has agreed to acquire Ceregene, a privately held biotechnology company focused on developing adeno-associated virus (AAV) gene therapies.

Sangamo BioSciences to Acquire Ceregene

specialty pharmaceutical companies Akorn 

and Hi-Tech Pharmacal have formed an agreement under which Akorn will acquire Hi-Tech for $640 million in cash. The deal, which is subject to customary closing conditions, is scheduled to close in the first quarter of 2014. The combined company will have sales in excess of $500 million, according to an Akorn press statement. 

Hi-Tech is a specialty pharmaceutical company developing, manufacturing, and marketing generic and branded prescription and over-the-counter (OTC) products. Hi-Tech specializes in difficult-to-manufacture liquid and semisolid dosage forms and produces and markets a range of oral solutions and suspensions as well as topical ointments and creams, nasal sprays, otics, sterile ophthalmics, sterile ointments, and gels products. 

The acquisition strengthens Akorn’s position in generic ophthalmic drugs and also broadens its product offering to include other niche dosage forms such as oral liquids, topical creams and ointments, nasal sprays, and otics. The deal also enhances Akorn’s retail presence in both prescription and OTC products. Akorn says it plans to capitalize on the manufacturing capabilities of Hi-Tech to further expand its presence in the private-label OTC business. On a product basis, Akorn currently has 57 abbreviated new drug applications (ANDAs) filed with FDA, and Hi-Tech has filed 18 ANDAs. 

Akorn expects to achieve between $15 million and $20 million in annual run-rate synergies within 12 months of close. 

Akorn will acquire Hi-Tech Pharmacal for $640 million.

Akorn to Acquire Hi-Tech Pharmacal

MedImmune, the global biologics R&D arm of 

, has agreed to acquire the biopharmaceutical company Amplimmune, which specializes in cancer immunology, for approximately $500 million, which includes an initial consideration of $225 million and deferred consideration of $275 million based on reaching predetermined development milestones. The deal, which is subject to customary regulatory closings, is expected to close in the third quarter of 2013. 

The acquisition will strengthen MedImmune’s oncology pipeline by obtaining multiple early-stage assets for its immune-mediated cancer therapy (IMT-C) portfolio, including AMP-514, an antiprogrammed cell death 1 monoclonal antibody (mAb). AMP-514 is in late-stage preclinical development, and Amplimmune expects to file an investigational new drug filing before the end of 2013. Other Amplimmune assets include multiple  preclinical molecules targeting the B7 pathways. Founded in 2007 and headquartered in Gaithersburg, Marlyand, Amplimmune is focused on developing costimulatory/co-inhibitory molecules that rebalance the immune system and are intended for treating cancer, autoimmune disease, infectious disease, and transplantation. Amplimmune has three biologic product candidates: AMP-224 is in Phase Ib trials in cancer; AMP-110 for autoimmune diseases in partnership with Daiichi Sankyo; and AMP-514 for cancer.

The acquisition builds on MedImmune's oncology R&D activities. MedImmune’s oncology research is focused on IMT-C, a therapeutic approach that may lead to durable and prolonged response rates across a range of cancer types. IMT-Cs are being designed for the immune system to counteract the tactics employed by cancer cells to avoid detection and attack the body. MedImmune's clinical-stage program include tremelimumab, an anti-OX40 mAb, and MEDI-4736, an anti-PD-L1 mAb. The acquisition of the Amplimmune technology and pipeline strengthens AstraZeneca's and MedImmune portfolio to enable the use of data-driven combinations of IMT-C molecules as well as combinations with highly targeted small molecules. 

AstraZeneca's MedImmune has agreed to acquire Amplimmune, which specializes in cancer immunology.

AstraZeneca's MedImmune To Acquire Amplimmune

, a biopharmaceutical company focused on the discovery and development of RNA-targeted therapies, has extended its existing partnership with Shire for treatments for rare genetic diseases.  

Under the terms of the extended agreement, Shire will have the right to nominate additional collaboration targets for drug discovery and development.  Santaris will receive an upfront payment and, consistent with the initial agreement, is eligible for research support, pre-clinical, clinical, and sales milestones, as well as royalties on each product emerging from the collaboration.

Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.

Shire and Santaris Extend Alliance to Develop LNA-drugs

Seeking to build its oncology drug portfolio, 

has agreed to acquire the biopharmaceutical Onyx Pharmaceuticals for $10.4 billion ($9.7 billion net of estimated Onxy cash). The deal, which values Onxy at $125 per share, has been approved by the board of directors of both companies and is expected to close in the fourth quarter of 2013, subject to customary closing conditions and regulatory clearance. 

Onyx Pharmaceuticals has a growing multiple myeloma franchise, which includes Kyprolis (carfilzomib) for injection already approved in the United States. Onyx holds global rights to Kyprolis, excluding Japan. Kyprolis has orphan-drug designation in the United States with exclusivity until July 2019, and patents in the US which extend until at least 2025. In addition, Onyx has three partnered oncology assets: Nexavar (sorafenib) tablets (an Onyx and Bayer HealthCare Pharmaceuticals compound), an oral kinase inhibitor, approved in the US for unresectable hepatocellular carcinoma and advanced renal cell carcinoma; Stivarga (regorafenib) tablets (a Bayer compound), an oral kinase inhibitor, approved in the US for for metastatic colorectal cancer; and palbociclib (a Pfizer compound), an oral, small molecule cyclin-dependent kinase 4/6 inhibitor, now in Phase III trials, to treat  ER+, HER2-negative advanced breast cancer. 

Amgen says that the acquisition of Onyx will add to Amgen's late-stage pipeline. This pipeline includes nine innovative products for which registration-enabling data are anticipated by 2016. Four of these products are oncology products. Onyx's pipeline complements Amgen's oncology portfolio, according to Amgen. 

Amgen acquires Onyx Pharmaceuticals for $125 per share in cash.

Amgen to Acquire Onyx Pharmaceuticals in $10.4 Billion Deal

has expanded by 30% its stability storage space for products that require International Conference on Harmonization (ICH)-specified environmental conditions.


The company’s stability storage rooms and chambers are fully validated to meet strict temperature, humidity, and uniformity controls. Chambers and rooms are monitored 24/7 and are cGMP compliant.


Parameter Stability Storage rooms and chambers have been mapped and validated for FDA-mandated long-and short-term shelf life studies under various temperature and humidity requirements.


In addition, the company offers back-up contingency storage to businesses whose own stability storage facilities prove inadequate because of space constraints, disastrous weather conditions, or electrical failures.
  

Parameter Stability Storage adds validated space in anticipation of pending contracts.