Perrigo Company plc Announces Acquisition Of OTC Products
In Australia

Perrigo Company plc has acquired a basket of value-brand OTC products sold in Australia and New Zealand from Aspen Global Inc. for $51 million in cash. The products are primarily sold through the mass retail channel and include the Herron? range of analgesics, vitamins and supplements. This basket of products is expected to generate at least $20 million in annual revenue.

Perrigo's Chairman, President and CEO Joseph C. Papa stated: "This announcement is the result of outstanding contributions from the entire team. The acquisition of OTC products in Australia enhances our position by broadening our product offering and increasing our relevance with the mass retail customers. This deal furthers our strategy to expand our Consumer Healthcare portfolio internationally, while making quality products more affordable for consumers and customers around the world."

From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri. The Company is the world's largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies.

Catalent Announces Agreement for Regenerative Therapies
Employing iPS Cells in Humans

Catalent Pharma Solutions, the global leader in advanced delivery technologies and development solutions for drug, biologic and consumer health products, has announced an agreement with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to make a major advancement toward one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.

Under this agreement, Catalent manufactures an anti-CORIN monoclonal antibody using its proprietary GPEx cell line expression technology for a planned clinical research project to develop an iPS cell-based transplant therapy for Parkinson’s disease at CiRA, which is directed by Professor Doctor Shinya Yamanaka, the joint winner of the Nobel Prize in Physiology or Medicine in 2012 for “the discovery that mature cells can be reprogrammed to become pluripotent”.

The anti-CORIN monoclonal antibody was discovered and developed through collaborative research between CiRA and KAN Research Institute, Inc., a research subsidiary of a major Japanese pharmaceutical company, Eisai Co., Ltd- Catalent has already engineered cell lines producing the anti-CORIN monoclonal antibody for CiRA using their GPEx technology, and the antibody has been shown to be useful for sorting CORIN-expressing cells in in vitro studies at CiRA. Under the agreement, Catalent will conduct further clonal selection and manufacturing of the monoclonal antibody under a properly conditioned environment for CiRA, which will use the antibody to select dopaminergic neurons derived from iPS cells and plans to transplant the selected cells into patients in a possible clinical research program upon receipt of regulatory approval. Catalent will also support CiRA, with formulation, production, and sterile fill/finish of the monoclonal antibody, aspects of the project that could not be handled within academia.

“It is a great honor to work with a team led by world renowned Professor Doctor Jun Takahashi,” commented Shingo Nakamura, Catalent’s Director of Biologics, Japan. “We are very excited to help accelerate the development of a unique regenerative therapy using our GPEx technology and look forward to working with CiRA to bring better treatments to market faster.”

Jonathon Arnold, Vice President and General Manager of Catalent Biologics, added: “We are witnessing an increased demand for biologics in the Asia Pacific market. Our GPEx technology, our expertise, and access to Antibody Drug Conjugates, combined with our investment in state-of-the art manufacturing facilities, mean that we are ideally placed to act as a partner to CiRA in this exciting project.”

Catalent’s GPEx technology produces high-yielding, stable mammalian cell lines and has been successfully applied in the manufacture of more than 500 different recombinant proteins, over 30 of whic

Analysis of China Current State of Export of API
in 2014: the Characteristic API Being Extremely Pop

2013 can be called as the most confusing and depressing year for the API (Active Pharmaceutical Ingredients) industry: the export of API being no longer successful, the amount of export continuously decreased with the decrease extent being widened. However, the new dawn in 2014 gradually appears: the characteristic API perhaps will become one hot spot of the industry due to the R&D boom of the innovative drugs in recent years.

The export data of characteristic API being obviously increased

Viewed from the export situation of part characteristic API ranking top ten of the amount of exports of 2013 and compared with the same period last year, the amount of exports appears with five increases and five decreases: it is worth noting that the increasing rate of amount of exports of five characteristic API is far greater than the decreasing rate of other characteristic API. For example, the amount of export of irbesartan is USD112.27 million, the growth rate being 79.30%; the amount of export of meropenem is USD57 million, the growth rate being 140.76%; the amount of export of spironolactone is USD54.74 million, the growth rate being 22.74%.

The characteristic API being extremely popular in 2014 and the initiatives for international certification of the enterprises being strong

The awareness of Chinese enterprises for international certification has become stronger. Totally 151 items of API main documents category II (DMF) were submitted to the U.S. FDA by the drug enterprises of our country before the end of November in 2013, accounting for 12.5% of the total items. Totally 504 API items of the EU EDQM certificate were passed by Chinese API enterprises and there had been 60 API of 44 units acquiring EDQM API certificate in 2013, which was the year with the largest number of acquiring this certificate in recent years.