“Ash Stevens’ hard work on their comprehensive environmental, health, safety and security program shows their commitment to constant improvement and to contributing to the quality of life in their community. SOCMA commends them on their Silver Award honors and encourages Ash Stevens to continue these efforts through the ChemStewards performance improvement program,” said SOCMA President Lawrence D. Sloan.

About Ash Stevens, Inc.
Ash Stevens, Inc. (ASI) is a full service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Detroit, Michigan, ASI has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule therapeutics. ASI is a longtime provider of contract research services to the National Institutes of Health and the National Cancer Institute and has worked on many of the drugs developed through these government agencies. To date, ASI has received eleven FDA manufacturing approvals for innovator APIs, including three Fast Track manufacturing approvals for the active ingredients in the oncology drugs Velcade®, Vidaza®, and Clolar®. Services offered by Ash Stevens include: process development and scale-up; cGMP manufacturing; the development and cGMP manufacture of highly potent APIs using barrier-isolation technology; comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards); and regulatory support for all phases of drug development and manufacturing. For more information, visit www.ashstevens.com.

About SOCMA
SOCMA is the only U.S. based trade association dedicated solely to the batch, custom and specialty chemical industry. Since 1921, we have represented a diverse membership of small, medium and large chemical companies, making us the leading authority on this sector. SOCMA has a global membership of more than 200 companies. For more information on our services and products, please visit www.socma.com.

About ChemStewards®
ChemStewards® is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement program.  ChemStewards® was created from industry’s commitment to reducing our environmental footprint.  Industry created ChemStewards® to meet the unique needs of the batch, custom, and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of chemicals, ChemStewards® is helping participants reach for superior EHS&S performance.  To learn more visit www.chemstewards.com.

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“For nearly 50 years we have been building a strong reputation to be a trusted partner in the life science industry – this expansion is possible thanks to our commitment to quality, delivery and client service as well as the forward-looking support of the local and state government,” said Dr. Stephen Munk, CEO, Ash Stevens. “We considered locations in other states that were closer to our customers, but we’ve always wanted to stay in Michigan and now we are committed to expanding our workforce and infrastructure in our home community and state.” 

The first phase involves the construction of a 10,000 sq. ft., state-of-the-art GMP storage and materials handling facility to accommodate the company’s current and projected increase in business. Other phases of construction include a new 2,250-gallon reactor bay with 500-gallon, 750-gallon and 1,000-gallon vessels for the large-scale manufacture of APIs. Ash Stevens also is consolidating its Detroit laboratories to a single site at the Riverview location within the next three to seven years.

“We’re happy to support and celebrate companies like Ash Stevens that are committed to growing and expanding in our community,” said Mayor Tim Durand, City of Riverview. 

Ash Stevens, Inc. 
Ash Stevens, Inc. (ASI) is a Contract Pharmaceutical Manufacturer founded in 1962. Headquartered in Detroit, Michigan, ASI has extensive experience with the development and scale-up of commercial APIs (Active Pharmaceutical Ingredients) with strength in oncology products. Ash Stevens shares a longstanding and successful relationship with the National Cancer Institute. Recently, ASI has received Food and Drug Administration manufacturing approvals for several innovator drugs, including the APIs in Velcade®, Vidaza®, and Clolar®—all three Fast Track approvals. The company has an excellent global regulatory compliance history and has been inspected by Ministries of Health from Japan, Korea, Mexico, Australia, European Union and the United States. Ash Stevens is a preferred contractor for the development and cGMP manufacture of innovator small molecule APIs for oncology and other therapeutic indications. For more information, visit www.ashstevens.com.

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Dr. Stephen A. Munk, president and CEO of ASI, attributed the success and sustained growth to the company’s commitment to providing quality work, on time delivery, and attentive client service. With over 45 years of experience, the company has built strong brand recognition in the Life Science industry as a trusted partner and supplier of quality small-molecule drug development and cGMP manufacturing services.  It is this commitment to quality, delivery, and client service that is fueling the current multi-year, multimillion dollar expansion at the company’s manufacturing facility in Riverview Michigan that will allow the company to better meet the needs of its clients and create new jobs in the state of Michigan. 

As further testament to ASI's dedication to quality pharmaceutical manufacturing in 2009, the Society of Chemical Manufacturers and Affiliates (SOCMA) honored Ash Stevens with two Silver Awards for commitment to performance improvements in Environmental, Health Safety and Security (EHS&S) practices. The awards are based on Ash Stevens achievements in meeting and exceeding compliance in two focus areas of SOCMA's ChemStewards® program: Planning and Operations as well as Employee Training and Engagement. The ChemStewards® program is uniquely designed to meet the specific needs for continuous improvement in EHS&S performance for the batch, custom, and specialty chemical industry. 

“One of our key strengths beyond providing quality chemistry and on time delivery of active pharmaceutical ingredients is attentive client service. We strongly value our client partnerships—we share their same goals and establish interactive relationships to facilitate rapid communication and problem solving,” said Dr. Munk. “We've seen our base of repeat clients grow this past year as evidence of our commitment to quality, on-time delivery, and client satisfaction.”

About Ash Stevens, Inc. 

Ash Stevens, Inc. (ASI) is a Contract Pharmaceutical Manufacturer founded in 1962. Headquartered in Detroit Michigan, ASI has extensive experience with the development and scale-up of commercial cancer APIs (Active Pharmaceutical Ingredients) and shares a longstanding and successful relationship with the National Cancer Institute. To date, ASI has 10 FDA approvals for drug substances that include manufacturing approvals for the active ingredients in Velcade®, Vidaza®, and Clolar®. The company has an excellent global regulatory compliance history and has been inspected by Ministries of Health from Japan, Korea, Mexico, Australia, European Union and the United States. Ash Stevens is a preferred contractor for the development and cGMP manufacture of innovator small molecule APIs for oncology indications. For more information, visit www.ashstevens.com.

Mr. Ammoscato’s presentation is part of the Chemistry in Cancer Research Working Group (CICR) educational session. Chaired by ASI President and CEO Stephen Munk, PhD, the session will highlight the challenges of developing and manufacturing highly potent APIs used in anti-cancer drugs. In addition to Ash Stevens, ARIAD Pharmaceuticals, Infinity Pharmaceuticals, and The National Institutes of Health (NIH) will present methods of addressing challenges in discovering and developing anti-cancer drugs. A schedule for the session is included below.

Educational Session Details

Session Title: From Chemistry to the Clinic, Part 3: Chemical Development – Translating a Potent Agent into a Registered Product
Date: Saturday, April 17
Time: 1:00 p.m. to 3:00 p.m. EST
Location: Room 147, Walter E. Washington Convention Center Chairperson: Stephen A. Munk, President and CEO of Ash Stevens Inc. Presentations:

1:00 PM On the road from research to reality: Pharmaceutical product development concepts for potent compounds, including AP24534, a novel multi-targeted kinase inhibitor. Christopher K. Murray, ARIAD Pharmaceuticals, Inc., Cambridge, MA

1:30 PM Discovery and development of the indenoisoquinolines topoisomerase I inhibitors. Yves G. Pommier, National Institutes of Health, Bethesda, MD

2:00 PM Pharmaceutical development challenges of the Hsp90 inhibitor IPI-504: A case study in controlling impurity. Kristopher M. Depew, Infinity Pharmaceuticals, Inc., Cambridge, MA

2:30 PM The role of the chemical development team in the regulatory approval of a cancer drug. Vince Ammoscato, Vice President of Operations, Ash Stevens Inc., Detroit, MI

About Ash Stevens, Inc. Ash Stevens, Inc.

(ASI) is a Contract Pharmaceutical Manufacturer founded in 1962. Headquartered in Detroit Michigan, ASI has extensive experience with the development and scale-up of commercial cancer APIs (Active Pharmaceutical Ingredients) and shares a longstanding and successful relationship with the National Cancer Institute. To date, ASI has 10 FDA approvals for drug substances that include manufacturing approvals for the active ingredients in Velcade®, Vidaza®, and Clolar®. The company has an excellent global regulatory compliance history and has been inspected by Ministries of Health from Japan, Korea, Mexico, Australia, European Union and the United States. Ash Stevens is a preferred contractor for the development and cGMP manufacture of innovator small molecule APIs for oncology indications. For more information, visit www.ashstevens.com.

Ash Stevens received two Silver Awards for its commitment to performance improvements in EHS&S Planning and Operations as well as Employee Training and Engagement, two of the five core principles of SOCMA's ChemStewards® program. The 2009 SOCMA Awards captures EHS&S activities during calendar 2008.

The awards are based on an individual facility's achievements towards meeting and exceeding one of the core principles of the ChemStewards® program. The ChemStewards® program sponsored by SOCMA ensures compliance and continuous improvement in the area of EHS&S performance focusing on five core principles: Stakeholder Communications, Product Stewardship, EHS&S Planning and Operations, Employee Training and Engagement and Resource Management and Waste Minimization.

SOCMA's ChemStewards® program was launched in 2005 and is uniquely designed to meet the specific needs for continuous improvement in EHS&S performance for the batch, custom, and specialty chemical industry.

Dr. Stephen A. Munk CEO and President of Ash Sevens, Inc. said, "We are both delighted and honored to receive these prestigious awards that recognize our commitment to sound EHS&S policies and practices."

"Ash Stevens was certified compliant by the ChemStewards® program in July of 2007 and was one of the earliest contract pharmaceutical manufacturers to be certified by this program. In a rapidly changing regulatory environment, these awards reflect Ash Stevens' ongoing engagement with sound administration and forward-looking practices in EHS&S compliance. We take our commitment to EHS&S at Ash Stevens very seriously because peoples' lives, livelihoods and investments depend upon that commitment," said Dr. Munk.

"Ash Stevens is at the top of their field and we commend them on their Silver Awards," said SOCMA President Joe Acker. "They are a great example of a small company that is doing an exemplary job on their environmental, health, safety and security program. Their hard work is a testament to their commitment to constant improvement and to contributing to the quality of life in their community."

About Ash Stevens, Inc.

Founded in 1962 in Detroit, Ash Stevens, Inc. (ASI) is an established contract pharmaceutical manufacturer that offers comprehensive small-molecule drug development and cGMP manufacturing services. ASI has a long and successful track record of developing and manufacturing APIs (Active Pharmaceutical Ingredients) for clients in the Life Science industry that includes 11 FDA approvals for innovator APIs (NCEs). ASI has an excellent regulatory inspection record that includes international inspections by Ministries of Health from Korea, Japan, Australia and the European Union (QP) in addition to the US FDA. ASI supports all facets of chemistry and manufacturing controls (CMC) related to the development of small-molecule APIs from early-stage development through commercial API manufacturing. Services offered by Ash Stevens include: process development and scale-up, cGMP manufacturing, the development and cGMP manufacture of highly potent APIs using barrier-isolation technology, comprehensive analytical capabilities (including method development, stability studies and qualification of reference standards) and regulatory support for all phases of drug development and manufacturing. With over 45 years of experience, Ash Stevens has a reputation for providing the highest quality of service to its clients and for delivering on time and on budget. For more information, visit www.ashstevens.com.

Detroit—May 13, 2009—Ash Stevens Incorporated (ASI), a full-service cGMP contract manufacturer, recorded a 2008 revenue increase of 25 percent over the previous year and ranked seventh on Crain's Detroit Business' list of the top 10 largest Detroit-area biotech companies.

Dr. Stephen A. Munk, CEO and President of ASI, attributed the company's success and sustained growth, which included new facility expansions and employees, primarily to client focus.

"To be successful, we have to share the same goals as our clients, be proactive in looking out for our client's interests, and be flexible in adapting to our client's needs," said Dr. Munk. "Our strong base of repeat business from clients who have worked with us in the past is evidence of our commitment to doing quality work, delivering on goals, and client satisfaction."

Amid a struggling Michigan economy, Dr. Munk remarked that one bright spot is the biosciences community, which enjoys strong support from the state of Michigan. Earlier this month, Michigan became one of the few states with legislative biotech initiatives in both the house and senate. State legislators agreed to form a senate task force on biotechnology and a house subcommittee on biosciences to grow resources for Michigan's biotech industry.

Michigan's private sector is also working towards a more robust biotech industry. ASI and seven other drug development contract service providers have recently formed the Michigan CMC Alliance, which provides chemistry, manufacturing and controls resources and strategies to life science companies. For more information, visit www.micmcalliance.com.

For more information, visit Ash Stevens at the 2009 BIO International Convention, May 18-21, 2009 at booth #3147.

About Ash Stevens, Inc.

Headquartered in Detroit, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the Federal Government. ASI has extensive experience in the development and scale-up of commercial cancer APIs and shares a longstanding and successful relationship with the National Cancer Institute. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 60 employees and holds a variety of patents covering topics including medicinal agents and manufacturing processes. For more information, visit www.ashstevens.com.

Detroit—January 23, 2009—Ash Stevens, Incorporated (ASI) has completed program requirements for and is now certified as compliant with SOCMA's ChemStewards® program. ChemStewards® is SOCMA's flagship environmental, health, safety and security (EHS&S) continuous performance improvement program. ChemStewards was created from industry's commitment to reducing the environmental footprint left by member's facilities. Industry created ChemStewards to meet the unique needs of the batch, custom and specialty chemical industry. As a mandatory requirement for SOCMA members engaged in the manufacturing or handling of synthetic and organic chemicals, ChemStewards is helping participants reach for superior EHS&S performance.

"ChemStewards certification sends a strong message to our employees and our community that Ash Stevens is committed to a safe and environmentally friendly operation. It gives our customers the assurance that we are committed to compliance with all applicable federal EHS&S regulations at our facility. This dovetails very nicely with the recent addition of a process safety laboratory here at Ash Stevens," said Dr. Stephen Munk, company president and CEO.

"Ash Stevens should be proud to be ChemStewards certified," said Joe Acker, SOCMA's President. "Their customers can rest assured that their business is being handled by a company that makes sound environmental, health, safety and security management a top priority. SOCMA's ChemStewards Program is the only EHS&S program designed specifically for the batch, custom and specialty chemical industry. Ash Stevens' participation indicates their commitment to compliance with federal regulation and building cooperation throughout the supply chain."

As an established contractor, ASI has been conducting process development and manufacturing of APIs in Michigan since the 1960s, and has developed substantial expertise in high-potency Active Pharmaceutical Ingredients (HPAPI), including cancer drugs. With more than 40 years of custom drug manufacturing experience, ASI has emerged as a premier contract research organization for developing highly potent anticancer agents. ASI's success in the industry stems from a goal-oriented, nimble research and development approach coupled with attention to detail and regulatory compliance programs. Today, the company has 11 FDA approvals for manufacturing.

ASI has invested more than $15 million in its manufacturing facility located in Riverview, Mich. over the past five years. These improvements have expanded the company's capabilities while integrating new technology creating a safe, effective product development and manufacturing processes. In addition, ASI has diversified its customer base while growing science-related jobs in Michigan.

About Ash Stevens, Inc.

Headquartered in Detroit, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the Federal Government. ASI has extensive experience in the development and scale-up of commercial cancer APIs and shares a longstanding and successful relationship with the National Cancer Institute. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 60 employees and holds a variety of patents covering topics including medicinal agents and manufacturing processes. For more information, visit www.ashstevens.com.

Detroit—January 12, 2009—Ash Stevens, Incorporated (ASI), a full service cGMP contract manufacturer, enhanced the speed and safety of scale-up with new investments in parallel synthesis and calorimetry instrumentation at its Riverview, Michigan Active Pharmaceutical Ingredient (API) development and manufacturing site.

The new equipment gives ASI’s Development team the ability to assess heats of reaction for the safe scale-up of processes. The system captures real-time data and provides electronic records useful for post-experiment analysis. Traditionally, an experienced scientist could conduct two concurrent experiments manually in the laboratory. With the new system, up to four experiments can be conducted simultaneously spanning a broad range of conditions. The new safety enhancements also include a Thermal Screening Unit used to evaluate the onset of thermal decomposition of reaction components.

“These investments allow us to rapidly optimize chemical processes and better understand process safety parameters prior to scale up,” said Dr. Stephen Munk, President and CEO of Ash Stevens. “Our customers will benefit from increased time savings.”

Slated for the third quarter of 2009, ASI will bring online a new three-reactor processing suite designed for hydrogenation and additional manufacturing capacity. The new suite

will include a 50-gallon glass-lined steel hydrogenation reaction vessel as well as house a pair of 100-gallon vessels.

For more information, visit Ash Stevens at Informex in San Francisco on January 27-30, 2009 at booth #939 or online at www.ashstevens.com. James M. Hamby, R.Ph., Ph.D., Director of Business Development for Ash Stevens, Inc. will be presenting an Exhibiter Showcase at Informex on Tuesday, January 27 at 4:00 pm in room 304 of the Moscone South Convention Center.

About Ash Stevens, Inc.

Headquartered in Detroit, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the Federal Government. ASI has extensive experience in the development and scale-up of commercial cancer APIs and shares a longstanding and successful relationship with the National Cancer Institute. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 50 employees and holds patents in both medicinal and process chemistry. For more information, visit www.ashstevens.com.

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Philadelphia—May 29, 2008—Rebecca Ahn, an industry expert with Ash Stevens Inc. (ASI), today will present the advantages of barrier isolation technology over cleanroom suites in the safe and efficient manufacture of Busulfex® at PharmaEd’s “Containment of Potent Compounds Conference” in Philadelphia. ASI is a full-service cGMP contractor that provides low-volume, high-value API (active pharmaceutical ingredients) to the pharmaceutical industry.

Busulfex®, the intravenous version of the drug Busulfan, is a highly potent drug, used as a pre-treatment regimen for bone marrow transplant patients with chronic myelogenous leukemia. The challenges with handling Busulfex® are two-fold. Human contact can easily introduce contaminants during processing. Moreover, without proper safeguards, Busulfex® can impair the immune system if accidentally inhaled. ASI is currently the only FDA approved supplier of the Busulfex® API.

Barrier isolation technology offers the best solution since the work area consists of a self- contained glove box to protect the worker from potentially dangerous compounds and to ensure that the compounds are protected from the environment. The isolator permits the entire range of tasks necessary to move the product from synthesis through filtration, washing, drying, sampling, packaging and product transfer.

“The glove box provides an enclosed setting that protects the operator from the product as much as it protects the product from the operator and the rest of the environment,” said Ahn, an ASI Senior Engineer.

A cleanroom environment does not afford the operator or the compound the same degree of protection. There is also no assurance that a person entering the cleanroom is wearing the necessary protective equipment, i.e. a Level C isolator suit. Of particular concern in large scale manufacturing processes, productivity in the isolator suits may be hindered due to limited mobility.

“Handling these compounds involves a great deal of manual dexterity. This is much harder to do and takes a lot longer if one is covered from head to toe – including fingertips – in an isolator suit,” said Ahn.

In addition to discussing the differences between barrier isolation and cleanroom technology, Ahn’s presentation will focus on the following:

• Design of a chemical process and options for the manufacture of potent compounds using barrier isolation technology

• Isolator design and cleaning requirements

• Managing FDA regulatory requirements

About Rebecca Ahn

Rebecca Ahn has been a Manager of Engineering and Operations with Ash Stevens Inc. for seven years. She has experience in process engineering, scale-up and manufacturing, both as a scientist and as a manager. She directs capital spending projects for the company’s manufacturing operation, including the installation of a low-temperature reactor suite and filter-dryer equipment with barrier isolation. She also manages production of ASI’s FDA- approved drugs. She received her Bachelor of Science degree in Chemical Engineering from the Georgia Institute of Technology.

About Ash Stevens Inc.

Founded in 1962 and headquartered in Detroit, Ash Stevens Inc., is a one of the premier chemical manufacturing organizations in the country and a leading provider of low- volume, complex Active Pharmaceutical Ingredients to the federal government and to the commercial pharmaceutical industry. Moreover, the company is well known for its expertise in the area of high-potency compounds. Today, Ash Stevens has more than 50 employees and holds a variety of patents covering topics from medicinal chemistry to process chemistry. The company maintains a state-of-the art manufacturing plant in Riverview, Mich., including reaction vessels with capacities up to 500 gallons. For more information, visit the company’s website at www.ashstevens.com.

About PharmaEd

Located in the United Kingdom, PharmaEd is a specialist medical education company, focusing on the information needs of clinical development and pharmaceutical strategic marketing staff. PhamaEd’s conference – Containment of Potent Compounds: Implementing Risked-Based Approaches and Ensure Safety through Strategic Containment Operations and Processes – will take place in Philadelphia at the Radisson-Plaza Warwick Hotel and will bring together experts in the field of potent compound containment. For more information, visit the organization’s website at www.pharmaedresources.com.

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Detroit—April 10, 2008—Ash Stevens Inc.TM (ASI) President and CEO Dr. Stephen Munk will chair an educational session for the Chemistry in Cancer Research Working Group (CICR) at the American Association for Cancer Research (AACR) annual meeting on Saturday, April 12 at the San Diego Convention Center.

Dr. Munk’s session will highlight the unique developmental challenges of safely manufacturing highly potent active pharmaceutical ingredients (APIs) used in cancer drugs. Speakers from Genzyme Corporation, SRI International, Infinity Pharmaceuticals, and Abbott Laboratories will participate in the session, titled “From Chemistry to the Clinic: Pathways for Drug Discovery and Development Part 4: Chemical Development: Translating a Potent Agent into a Registered Product.”

About Ash Stevens, Inc.

Headquartered in Detroit, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the Federal Government. ASI has extensive experience in the development and scale-up of commercial cancer APIs and shares a longstanding and successful relationship with the National Cancer Institute. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 50 employees and holds patents in both medicinal and process chemistry. For more information, visit www.ashstevens.com.

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Detroit—February 6, 2008—Ash Stevens Inc.TM (ASI), a developer of high quality, small- molecule Active Pharmaceutical Ingredients (APIs), upgraded its Riverview, Mich. manufacturing facility with new state-of-the-art equipment.

ASI installed a new Bruker Biospin 400 MHz Avance III nuclear magnetic resonance (NMR) instrument. Equipped with a dual proton/carbon-13 probe, the NMR will enable the company’s chemists to rapidly obtain detailed analytical and structural information. In addition, ASI will place its third Rosenmund filter-dryer online in 2008. The filter-dryer will be equipped with glove-box technology for handling potent and air sensitive cGMP APIs in a contained environment.

“These investments in our Riverview facility will help us maintain our high standards and satisfy increasingly robust manufacturing demand,” said Dr. Stephen Munk, President and CEO, ASI. “With more than 45 years of experience and 11 FDA approvals to manufacture innovator APIs, Ash Stevens has earned a reputation as the premier provider of quality contract pharmaceutical manufacturing services for specialized APIs.”

Headquartered in Detroit, Ash Stevens was founded in 1962 to service the chemical research needs of the federal government. The company has since expanded in scope, becoming a leading chemical research organization and provider of specialized APIs to both the federal government and the commercial pharmaceutical industry. Today, ASI has expertise in high potency compounds and holds a variety of patents in medicinal and process chemistry. The company maintains research laboratories in Detroit and a state-of-the art, cGMP compliant manufacturing plant in Riverview, Mich. with total reactor capacity of 1,500 gallons.

About Ash Stevens, Inc.
Headquartered in Detroit, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the Federal Government. ASI has a total of 11 FDA approved drug substances in its portfolio. The company has more than 50 employees and holds patents in both medicinal and process chemistry. For more information, visit www.ashstevens.com.

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