Pharmaceutical Jobs

Radiation oncology company Accuray has implemented a workforce re-alignment designed to position its workforce more appropriately for the company’s growth strategy and to help achieve cost synergies associated with the acquisition of TomoTherapy Incorporated.

The move will result in a cut in Medical Device Jobs. The re-alignment affects approximately 51 positions throughout the company, or approximately 5% of the company’s total workforce, with approximately 29 positions eliminated effective November 15, 2011 and approximately 22 positions to be eliminated in phases throughout the remainder of fiscal year 2012.

All affected employees have been notified.

This action is consistent with the company’s stated financial goal of a reduction in operating expenses to approximately 45 percent of revenue by the end of fiscal year 2013.

The company estimates the total restructuring-related charges associated with this workforce re-alignment to be approximately $1.7 million in cash related to employee severance pay and related expenses. The company expects to record most of the restructuring charge in the second fiscal quarter of 2012, and the remainder in the third and fourth fiscal quarters of 2012.

Approximately 135 positions from pre-acquisition TomoTherapy and Accuray have left the company during and since completion of the acquisition, including the positions with this workforce re-alignment.

Accuray reported losses of $26.5 million on sales of $100.5 million for the three months ended September 30.

By comparison, for the quarter ended September 30, 2010 the sum of the net loss reported by Accuray and TomoTherapy as separate companies if combined totaled $16.6 million.

During the first quarter of fiscal 2012, $39.2 million of new system orders were added to backlog, resulting in a total system backlog of $270.8 million, a decrease of 6.2 percent from the prior quarter.

Health Diagnostics Laboratory (HDL) has chosen the city of Richmond to expand and grow its business.

This major expansion will occur in two phases in the Virginia BioTechnology Research Park. The initiative will also result in new biotech jobs. Phase 1 will begin in early 2012 with a capital investment of $38.5 million in building redevelopment and machinery and equipment and the creation of an additional 353 net new jobs.

Phase 2 will occur after the completion of Phase 1 and will include an additional capital investment of $30 million and the creation of 300 additional net new jobs.

“This $68.5 million capital investment and 653 net new jobs will bring HDL’s employment to over 950 employees and makes HDL a major employer in the city of Richmond,” said Mayor Dwight C. Jones.

HDL, a CAP accredited leader in health management, offers a comprehensive test menu of risk factors and biomarkers for cardiovascular and related diseases. It improves and saves lives by preventing heart disease through personalised patient care and advanced laboratory testing.

One in two people die from heart disease every year, said Tonya Mallory, President and CEO of HDL.

“This is more than the next seven causes of death combined, including cancer. Adding to the challenge, traditional cholesterol testing fails to identify up to 40-50% of the population at risk for cardiovascular disease and death,” said Mallory.

Mallory added, “Despite these alarming statistics, we can beat cardiovascular and related diseases, and we’re proving it every day at our advanced laboratory in Richmond, Virginia. Our newest expansion marks the success of not only Health Diagnostic Laboratory, but the growth of the Life Science community throughout Richmond, and Virginia as a whole.”

Evonik Industries has completed the acquisition of the assets of SurModics Pharmaceuticals, a subsidiary of SurModics, through its U.S. affiliate Evonik Degussa.

The acquisition gives Evonik ownership of SurModics’ parenteral dosage forms services and bioresorbable polymers business.

The new Evonik site will be named Birmingham Laboratories.

As far as Pharmaceutical Jobs are concerned, there is no adverse impact on the same. All employees of SurModics Pharmaceuticals will transfer to Evonik, assuring full business continuity from the first day.

The Birmingham, Alabama-based business will be integrated in Evonik Degussa, headquartered in Parsippany, N.J.

Earlier this month, Evonik Industries reached an agreement to acquire the Pharmaceuticals business of SurModics, headquartered in Eden Prairie, Minnesota, USA.

Following the acquisition of the Resomer business from Boehringer Ingelheim in March this year, Evonik is now strengthening the formulation services business for pharmaceutical applications. The new acquisition enables Evonik to further develop its health care business.

SurModics Pharmaceuticals is a specialist in injectable drug delivery systems. The new business includes two facilities for the development and manufacturing of polymers and drug delivery systems. The company is located in Birmingham (Alabama, USA) and employs, approximately 80 pharmaceutical experts. In 2010, the total revenues amounted to more than $15 million.

Boehringer Ingelheim Pharmaceuticals has shared that it has made more than $350 million worth of capital investments throughout its U.S. operations this year, in order to further bolster its drug discovery, development and manufacturing capabilities.

The company’s latest investment is a 72,000 square-foot research and development facility at the company’s U.S. headquarters in Ridgefield, Connecticut.

When complete the $65 million facility will handle production of active pharmaceutical ingredients used in early development activities. Products developed here, if approved, move on to Boehringer Ingelheim’s full-scale R&D facilities in Ohio and Virginia, as well as Germany and Italy.

This new R&D facility will help generate life-saving drugs.

These initiatives are also resulting new Pharmaceutical Jobs.

Boehringer Ingelheim is expanding its critical work right here in Connecticut, helping to grow both jobs and healthcare, said U.S. Senator Richard Blumenthal (D-Conn.).

The research that will take place at this facility will put successful medical ideas to work for millions of additional patients, all while creating jobs here in Connecticut, said Congressman Jim Himes (D-Conn.).

In August, the company confirmed its investment in a new drug safety assessment building in Ridgefield, Conn. The $42 million project is scheduled to be completed in 2013 and will provide space for non-clinical safety studies.

In September, Boehringer Ingelheim Roxane opened a new $50 million High Containment Operations facility in Columbus, Ohio in order to meet a growing market demand for high potency and oncology products.

In addition to these capital investments, Boehringer Ingelheim gained a presence on the West Coast with the acquisition in March of Boehringer Ingelheim Fremont, Inc. The facility, acquired from Amgen, manufactures biological medicines, and consists of more than 300,000 square feet for laboratories, manufacturing and process development suitable for clinical and market supplies.

APC Ltd, a new pharmaceutical research and technologies company, plans to create 20 predominantly high skill jobs within the next two years.

APC has already hired three permanent, PhD qualified engineers and chemists and plans to grow to 20 Pharmaceutical Jobs by 2013.

The company has been co-founded this year by Professor Brian Glennon and Dr Mark Barrett as a spin-out from UCD’s (University College Dublin) School of Chemical and Bioprocess Engineering. The company enables pharmaceutical companies to deliver their medicines to market by providing these companies with engineering and technology solutions. APC is currently investing in technology research and development and plans to launch additional products, services and processing technologies to the market in 2013.

Award

It has also emerged that the company has won the NovaUCD 2011 Start-Up Award after being declared overall winner of the 16th NovaUCD Campus Company Development Programme. NovaUCD, the Innovation and Technology Transfer Centre, is the hub of knowledge transfer activities at University College Dublin. NovaUCD is responsible for the commercialisation of intellectual property arising from UCD research and for the development of co-operation with industry and business.

In addition to the NovaUCD 2011 Start-Up Award, APC was also presented with a cheque for €5,000, €6,000 worth of professional services from Deloitte, €3,000 worth of legal services from Arthur Cox, €1,000 worth of business and taxation consultancy from Delaney Financial Consultancy and NewMarket Partnership and six-months free desk space at NovaUCD.

New Jersey Economic Development Authority (EDA) has confirmed that 75 emerging technology and biotechnology businesses have been approved to share the $60 million allocation available through the State of New Jersey’s innovative Technology Business Tax Certificate Transfer Programme.

New Jersey Governor Chris Christie Fiscal Year 2012 budget increased funds by $30 million over last year’s allocation.

This competitive programme enables companies to sell New Jersey tax losses and/or research and development tax credits to raise cash to finance their growth and operations.

The 75 applicants approved this year are estimated to receive, on average, approximately $800,000, more than double last year’s average.

Administered by the EDA and the Department of Treasury’s Division of Taxation, New Jersey-based technology or biotechnology companies with fewer than 225 U.S. employees may be eligible to sell net operating losses and research and development tax credits to unrelated profitable corporations for at least 80 percent of their value, up to a maximum lifetime benefit of $15 million per business.

To further help New Jersey grow its reputation as a home for innovation, Governor Christie signed into law a measure to increase the R&D credit to 100 percent. Previously, R&D spending in New Jersey was used to offset up to 50 percent of corporate tax liability. The new law allows critical and economically-beneficial R&D spending in the state to be used to offset all of the corporate tax liability.

The Governor also announced in August an expansion of the EDA’s Edison Innovation Fund to support emerging technology and biotechnology companies that have attracted funds through angel and venture capital investors.

Such initiatives not only result in economic development but also pave way for new biotech jobs.

Earlier this month, Christie announced that Allergan plans to open a new research and development facility in New Jersey that will create several hundred new jobs over the next three to five years and inject an estimated $12 million of private investment into the state’s economy. The company is currently narrowing down location options for their new research and development facility. Allergan currently employs 20 people at a subsidiary in Bedminster. The company has a research and development office in New Jersey focused on the development of pharmaceuticals for the past four years.

Global biopharmaceutical company UCB has reportedly presented its new production centre in canton Fribourg.

This new unit will be one of the largest in Europe and when finished should allow the creation of 120 to 140 new jobs, UCB Executive Vice President Michele Antonelli told reporters, according to a report filed by swissinfo.ch.

It was in December last year when the company initiated a project to build in-house biotech microbial manufacturing capacity in Bulle, Switzerland to secure demand for its core product Cimzia (certoluzimab pegol). The new manufacturing unit should be operational in 2015 and requires an investment of €250 million in two steps, the company had shared then.

“We want to be able to meet our projected future demand for 2015 and beyond for Cimzia – by adding internal capacity to our existing capacities with our productions partners,” Antonelli said then. “Our site in Bulle is the right place and most cost effective location to build our own biotech manufacturing unit which enables us to further improve our productivity at attractive terms. The new unit together with the bio-pilot-plant under construction in Braine l’Alleud, Belgium will also strengthen our ability to deliver our future biological products.”

As far as its operations are concerned, the company’s CEO Roch Doliveux believes the next 18 months are important for UCB: the full effect of the generic erosion of Keppra will be realised and at the same time UCB will continue to invest heavily in its new medicines and its pipeline portfolio.

“Once we have seen the generic erosion plateauing during the second half of 2012 – with the growth going forward, we could experience a decade with no major patent loss, sustainable growth and an exciting pipeline coming to market,” Doliveux as the company released its Interim Report for the first nine months of 2011.

Revenue in the first nine months of 2011 reached €2451 million driven by the growth of core medicines Cimzia, Vimpat and Neupro combined with the solid performance generated by the established product portfolio, especially Keppra and compensating for generic erosion of mature products.

In the first nine months of 2011, UCB’s core medicines Cimzia, Vimpat and Neupro delivered growth reaching combined sales of €445 million, +54% at actual exchange rates; +60% at constant rates compared with the first nine months in 2010.

Total revenue is expected to exceed 3.1 billion in 2011.

Medical device company MAKO Surgical Corp. is to build its RIO Robotic Arm Interactive Orthopedic system at a new Fort Lauderdale facility.

The initiative is to result in new Medical Device Jobs. The company is projected to bring nearly 100 new jobs to South Florida.

Founded in 2004, MAKO currently does business with approximately 82 Florida-based suppliers.

The company markets both its RIO Robotic Arm Interactive Orthopedic System and proprietary RESTORIS family of implants to surgeons for a procedure called MAKOplasty that provides a less invasive method for knee resurfacing and a new procedure for Total Hip Arthroplasty. The RIO is a surgeon-interactive tactile surgical platform that incorporates a robotic arm and patient-specific visualisation technology, which enables precise, consistently reproducible bone resection for the accurate insertion and alignment of MAKO’s RESTORIS implants, according to the company.

Recent developments

For the nine months ended September 30, 2011, revenue was $51.6 million, primarily generated from the sale of thirty RIO systems, 12 MAKOplasty THA applications, 4,674 MAKOplasty procedures performed and warranty and maintenance services provided, compared to $29.5 million for the nine months ended September 30, 2010.

In September 2011, MAKO commercially launched MAKOplasty Total Hip Arthroplasty (THA). Subsequent to the commercial launch, 12 MAKOplasty THA applications were sold through September 30, 2011.

As per the information available, 11 RIO systems were installed and customer accepted at domestic commercial sites during the third quarter, bringing MAKO’s worldwide commercial installed base of RIO systems to 97 systems as of September 30, 2011, of which 95 are installed domestically.

During the third quarter, 1,813 MAKOplasty procedures were performed, of which 1,752 were performed at domestic sites. The 1,813 MAKOplasty procedures performed represent a 16% increase over the procedures performed in the second quarter of 2011 and a 122% increase over the procedures performed in the third quarter of 2010.

Geron is eliminating 66 full-time positions. The development emerged as it has chosen to focus on its first-in-class oncology programmes.

As a consequence, Geron will discontinue further development of its stem cell programmes and is seeking partners for these assets. The company’s decision to cut biotech jobs represents 38% of its workforce. As a result, the company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.

The company shared that in the current environment of capital scarcity and uncertain economic conditions, it intends to focus its resources on advancing its Phase 2 clinical trials of imetelstat and GRN1005.

“These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months,” said Geron’s Chief Executive Officer, John A. Scarlett, M.D.

“By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels.”

The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the company’s research and clinical-stage assets.

Status

Imetelstat, Geron’s lead telomerase inhibitor, is currently being evaluated in four Phase 2 clinical oncology studies for the following indications: non-small cell lung cancer, breast cancer, essential thrombocythemia and multiple myeloma.

Geron expects top-line data from these trials to be available before the end of the fourth quarter of 2012.

GRN1005, an LRP-directed peptide-drug conjugate, is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. Geron expects top-line data from these trials to be available before the end of the second quarter of 2013.

Plans

Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programmes.

Dr. Scarlett said stem cells continue to hold great medical promise.

“We believe that our leadership role in the field and the quality of our stem cell assets-which are widely recognised as being among the most innovative, comprehensive and advanced cell therapy programmes in the world-will be an important point of differentiation in our discussions to partner these assets,” said Dr. Scarlett.

In order to facilitate transfer of these programmes to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.

Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events.

Stryker Corporation has announced its intention to implement focused workforce reductions of approximately 5% of its global workforce and other restructuring activities.

Such activities, which will result in a loss of Medical Device Jobs, are anticipated to reduce annual pre-tax operating costs by over $100 million beginning in 2013.

The targeted reductions and other restructuring activities are being initiated to provide efficiencies and realign resources in advance of the new Medical Device Excise Tax scheduled to begin in 2013, as well as to allow for continued investment in strategic areas and drive growth despite the ongoing challenging economic environment and market slowdown in elective procedures, stated the company.

The reductions and restructuring activities are expected to be substantially complete by the end of 2012. Stryker will provide employees affected by these reductions with severance packages, counseling and job placement services.

The company expects to record pre-tax restructuring charges related to these reductions and restructuring activities totaling approximately $150 million to $175 million, of which approximately $85 million to $95 million are expected to be recorded in the fourth quarter of 2011.

Last month the company shared its third quarter results. Its consolidated third quarter 2011 net sales of $2.03 billion increased 14.9% over the prior year. Net sales grew by 6.1% due to increased unit volume and changes in product mix, 7.6% as a result of acquisitions, and 3.2% due to the favourable impact of foreign currency exchange rates, which were partially offset by an unfavorable impact of 2% due to changes in price.

Stephen P. MacMillan, Chairman, President and Chief Executive Officer, mentioned that Stryker is on track to achieve double-digit sales growth in 2011.