In The Field

PERSONNNEL

New Jersey Pharmaceutical Companies Report Hiring Difficulties

Trenton, NJ (May 18)—Pharmaceutical and medical technology companies in New Jersey have found a striking disparity between six high-demand occupations and the number of qualified workers to fill those positions, according to a report issued by the HealthCare Institute of New Jersey (HINJ). Modest job growth in this field is expected for the next four years, states the report.

Distribution of Pharmaceutical and Medical Technology Employment in New Jersey by Functional Area, 2006. (www.hinj.org/UploadedFiles/HINJ_workforce_cond.pdf)

Prepared by Rutgers University's John J. Heldrich Center for Workforce Development, the report, "The Workforce Needs of New Jersey's Pharmaceutical and Medical Technology Industry," was based on an online survey of two-thirds of HINJ member companies in spring 2006. These member companies represent 38,000 of the 60,000 jobs at HINJ member companies.

The occupations found to be in high demand are: product and marketing managers, clinical scientists, regulatory affairs managers, medical doctors, biostatisticians, and engineers. As of 2006, only one quarter of jobs in New Jersey were in basic research and clinical development whereas half of all jobs in the sector were in corporate administration, marketing, and sales.

In the technical operations/manufacturing category, which accounts for 15% of the current related workforce in the state, 38% of open positions in this area are attributed to growth. According to the report, six occupations in this category, along with quality management, have moderate levels of employment, including mechanical engineers, manufacturing engineers, and quality control managers.

Adding to the overall problem is the fact that there are low numbers of college students graduating with degrees, including graduate degrees, in the subjects needed to work in the pharmaceutical and medical technology industry.

"The good news is that the industry is continuing to produce high-skilled, high-wage jobs. The bad news is that we may not have enough people to fill them," said Bob Franks, president of HINJ, in a HINJ news release.

To bridge the gap, the report urges institutions of higher learning to encourage students toward math and science disciplines. "Our state's pharmaceutical and medical technology companies are struggling to find qualified workers in six key occupations," said Dr. Carl Van Horn, professor and director of the Heldrich Center, in the release. "New Jersey's colleges and universities must play a stronger, more focused role in preparing students for these career opportunities."

To carry out this call to action, the HINJ report provides a detailed roadmap for industry-education partnerships that could benefit both students and HINJ companies, the latter of which has an estimated impact of $27 billion on New Jersey's economy.

Reacting to the report, New Jersey's Chief of Economic Growth Gary Rose stated that, "Bringing state government and higher education resources together was a priority outlined in the [governor's] economic growth strategy and will be a focus going forward," according to the release.

Added Commissioner David J. Socolow of the New Jersey Department of Labor and Workforce Development, "The report gives us insight into this industry's employment needs. It reflects the areas that are being addressed through our $2.8 million investment in High-Growth Workforce Investment Grants over the past year, funding training partnerships with employers in the pharmaceutical and biotechnology sectors. We are also working to meet the Life Sciences industry's workforce needs through a Workforce Innovations in Regional Economic Development (WIRED) initiative that recently received a $6.6 million federal grant for the Delaware Valley Innovation Network in southwestern New Jersey, southeastern Pennsylvania, and Delaware."

Fifteen of twenty-two HINJ companies responded to the survey, which targeted functional area, occupational title, educational level, and degree, while data were collected on numbers of employees, job openings, recent hires, and employment projections. Structured interviews were conducted with human resources managers as well. The full report may be found at www.hinj.org/UploadedFiles/HINJ_workforce_cond.pdf.

-Angie Drakulich

DRAFT GUIDANCE

FDA Issues Draft Guidance for Labeling Prescription Drugs

Rockville, MD (May)—The US Food and Drug Administration (FDA) issued a draft guidance "Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information."

The guidance is meant to help applicants and review staff in FDA's Center for Drug Evaluation and Research "determine when a drug belongs to an established pharmacologic class" and "how to select the appropriate word or phrase that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information of approved labeling."

According to a final rule published by FDA in January 2006, a drug that is a member of an established pharmacologic class must have the name of the class and the drug's indications clearly labeled under the Indications and Usage section of Highlights. Pharmacologic class is defined on the basis of the drug's mechanism of action (MOA), physiologic effect (PE), or chemical structure (CS).

According to the new draft, a single drug can have multiple scientifically valid pharmacologic classes. Only the pharmacologic classes that are clinically meaningful (that is, they enhance the ability of professionals to understand the therapeutic effects or undesirable effects of the drug) as well as scientifically valid can be the drug's established pharmacologic class. The draft goes on to give several examples of how to determine the correct pharmacologic class for a drug and the circumstances in which a combination of established pharmacologic classes may be included on the drug's label.

FDA goes on to state that new drugs undergoing review for marketing or licensing approval will have their proposed established pharmacologic class reviewed by FDA for scientific validity based on submitted evidence that supports the claim that the pharmacologic class is known and relevant to the indication under review. If an applicant wishes to update the labeling for an approved drug, the addition of an established pharmacologic class term to the Indications and Usage section must be proposed and submitted in a prior-approval labeling supplement.

-Brianne Harrison

COMPANY NOTE

Baltimore, MD (May 14)—Students at Johns Hopkins University developed a thin strip that dissolves in the mouth and is capable of delivering rotavirus vaccine to infants. The film dissolves within one minute, prompting the baby to swallow the vaccine. The medication is coated with a material that protects it from stomach acids but allows it to be released in the small intestine. The vaccine will be especially useful in developing countries, where rotavirus currently causes more than 500,000 deaths per year. Current vaccines must be chilled for transport and storage, making delivery to impoverished areas difficult and expensive. The strips are easy to transport and do not require refrigeration.

PEOPLE NOTE

Foster City, CA (May 10)—Gilead Sciences, Inc. promoted Paul Carter to senior vice-president of international commercial operations. Carter joined the company in 2006 as leader of Gilead's European commercial organization. He previously held various positions at GlaxoSmithKline.

ACQUISITION

Merck Sells Generics Business to Mylan Labs

Darmstadt, Germany (May 13)—Mylan Laboratories Inc. (Canonsburg, PA) and Merck KGaA (Darmstadt, Germany) have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics. The $6.7-billion, all-cash transaction is expected to close later this year, subject to regulatory review. Merck Generics boasts a product portfolio comprising 400 substances, dosage forms, and drug-delivery systems.

In a prepared statement, Karl Ludwig-Kley, chairman of the executive board at Merck KGaA, said the company will now focus its resources on growing its pharmaceuticals and chemicals business sectors. In 2006, Merck's generics division accounted for 29% of Merck Group sales and 28% of the group's operating result, with sales rising 6.9% in 2006. Merck Generics employs nearly 5000 people worldwide.

Mylan operates through Mylan Pharmaceuticals (generic pharmaceuticals), Mylan Technologies (transdermal patches, generic and brand-name), and UDL Laboratories (supplier of unit dose pharmaceuticals). Mylan also owns a controlling interest in Matrix Laboratories, which produces active pharmaceutical ingredients.

Mylan has stated that it "does not anticipate significant reductions in headcount at Mylan, Matrix, or Merck Generics" as a result of the transaction.

-Maribel Rios

ACQUISITION

Sun Pharmaceutical Agrees to Acquire Taro

Mumbai, India (May 21)—Sun Pharmaceutical Industries and its subsidiaries signed definitive agreements to acquire Taro Pharmaceutical Industries (Haifa Bay, Israel), a generics manufacturer with subsidiaries and manufacturing operations in the United States, Canada, and Israel.

Sun will fund the $454-million acquisition with internal accruals and proceeds from its $350-million foreign-currency convertible bond. The transaction values Taro's equity at $230 million, or $7.75 per share. The value is a 27% premium above Taro's May 18, 2007 closing price of $6.10 per share. Sun Pharma will refinance $224 million of Taro's net debt and grant Taro immediate liquidity by providing the company with $45 million in interim financing.

Taro specializes in dermatological and topical products such as the "Ovide" lice treatment. The company also manufactures cardiovascular, neuropsychiatric, and anti-inflammatory therapeutics. Taro's manufacturing sites produce topical creams and ointments, liquids, capsules, and tablets. Sun believes Taro's production capabilities will complement its manufacturing and development structure in the US. In addition, Taro manufactures active pharmaceutical ingredients (APIs), including steroids.

Sun is a specialty pharmaceutical company that manufactures branded generics. The company has product-development and process-chemistry capabilities and manufactures APIs and dosage forms.

The all-cash deal is subject to the approval of Taro's shareholders and the relevant regulatory authorities.

-Erik Greb

COMPANY NOTE

Basel, Switzerland (May 29)—Roche formed an agreement with two African manufacturing companies, Addis Pharmaceutical Factory in Ethiopia and Varichem Pharmaceuticals in Zimbabwe, to transfer technology related to the manufacture of an HIV medication. The agreement is part of Roche's Technology Transfer Initiative, which provides technical expertise and guidance for the processes to produce "Saquinavir," Roche's HIV medication. A team from Roche will work onsite at the manufacturing facilities in Africa and from the company's headquarters in Switzerland to transfer the technology. The companies will be able to produce Saquinavir for Ethiopia, Zimbabwe, and any other country within sub-Saharan Africa or defined as "least developed" by the United Nations.