Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Adeline Siew, PhD

AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND’s Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca. The agreement came after data suggested that nanomedicines such as Accurins could selectively accumulate in diseased tissues and cells, leading to higher drug concentrations at the site of the tumour and more importantly, reduced exposure to healthy tissues. 

Both companies will work together to complete Investigational New Drug (IND)-enabling studies of the lead Accurin, identified from a previously-completed feasibility programme. Under the terms of the agreement, AstraZeneca will acquire exclusive development and commercialization rights, while BIND will lead manufacturing during the development phase. Bind is eligible to upfront and pre-approval milestone payments totaling $69 million, and more than $130 million in regulatory and sales milestones and other payments as well as tiered single to double-digit royalties on future sales. 

"We are excited to grow this collaboration with AstraZeneca," said Scott Minick, President and CEO of BIND in a 

. "One year ago, BIND started several feasibility projects with major pharmaceutical companies. Our collaboration with AstraZeneca is the first one completed and had very successful results. Due to the advanced nature of this programme, we now plan to move an Accurin with optimised therapeutic properties quickly into product development. "

In the same statement, Susan Galbraith, head of AstraZeneca’s Oncology Innovative Medicines Unit, said that, "AstraZeneca believes that targeted therapies which specifically address the underlying mechanisms of disease are the future of personalized cancer treatment. Our oncology teams are actively exploring a range of platforms to deliver targeted therapies, with a strategic focus on unlocking the significant potential of nanoparticles in cancer treatment. We view BIND’s targeted nanomedicines as a leading technology in this field." 

Articles

AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND's Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca.

AstraZeneca Seals Cancer Nanomedicine Deal with BIND Therapeutics

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India. 

 "The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients. We believe that introducing etacept at a lower cost (of 30% lesser as compared to the innovator) will enable access of this drug to a greater number of patients in India," commented Dr Jaideep Gogtay, medical director of Cipla in a company’s 

Etacept contains the biologic etanercept, which is produced by recombinant DNA technology. The product, manufactured by China's Shanghai CP Guojian Pharmaceutical Co. Ltd., is available as a lyophilized powder for subcutaneous injection. Since its launch in China by Shanghai CP Guojian Pharmaceutical Co. Ltd. in 2006, more than 50 000 patients have been treated with etanercept. According to Cipla, the drug has demonstrated clinical efficacy and safety in Indian patients. A recent study showed that for patients who were successfully treated with etanercept for 6 months, a 50% reduction in dose provided the same benefit as continuing with the current dose. 

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

Cipla Launches First Biosimilar of Etanercept in India for Rheumatic Disorders

Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level. 

Superiority for HbA1c lowering was also investigated. At week 52, patients receiving dulaglutide 1.5 mg showed statistically superior reduction in HbA1c from baseline compared with those on insulin glargine (AWARD-2). Dulaglutide 1.5 mg dose in combination with insulin lispro was also found to be statistically superior in reducing HbA1c from baseline at week 26 compared with insulin glargine plus insulin lispro (AWARD-4).  

The most commonly reported adverse events were gastrointestinal-related, consistent with finding from previous studies of dulaglutide. 

Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being developed for the treatment of type 2 diabetes. Positive top-line results were reported in October 2012 for other completed AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) Phase III trials—AWARD-1, AWARD-3 and AWARD-5. All three trials met the primary efficacy endpoints (i.e., reduction in HbA1c following treatment with dulaglutide 1.5 mg). The five AWARD studies (1-5) will support regulatory filings of dulaglutide. 

 "Dulaglutide, if approved, further advances our efforts to offer a broad portfolio of therapies for people with diabetes, many of whom have unique needs," said Enrique Conterno, president of Lilly Diabetes in a 

. "The results of our Phase III dulaglutide trials are encouraging and we look forward to sharing more details on the AWARD studies at upcoming scientific meetings." 

Detailed data from the AWARD studies will be presented at scientific meetings in 2013 and 2014. The company expects to submit regulatory filings for dulaglutide in 2013. 

Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level.

Positive Phase III Results for Lilly's Dulaglutide in the Treatment of Type 2 Diabetes

Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user. 

Viscosity is a challenge for many biopharmaceutical formulators given that a number of biologics are highly viscous. The automatic delivery of high-viscosity drugs is an important milestone for parenteral drug delivery. There is currently no known such device on the market that can deliver such high viscosities. 

 by the company, "there has been no effective way of delivering high-viscosity drugs through a prefilled syringe, without extreme pain to the patient (due a large needle bore) and physical discomfort." Oval novel innovation now offers potential for drugs to be administered by the patient in the comfort of their own home. 

Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user.

Oval's Innovative Autoinjector Enables Delivery of High-Viscosity Formulations

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.  

 "Today's announcement further advances New York's reputation as a leader in the biotech industry," commented Governor Andrew M. Cuomo in a 

. "This administration has had a laser-like focus on creating an environment where companies, such as Regeneron, can grow and invest. The expansion of Regeneron's headquarters and the addition of hundreds of new high-skill jobs is great news for Westchester County and great news for New York." 

Two new buildings with 300 000 square feet of laboratory and office space will be added to Regeneron's site at the Landmark at Eastview in the Town of Mount Pleasant in Westchester, New York.  At present, Regeneron occupies approximately 590 000 square feet of space at this site and is expanding to include another 85 000 square feet of additional space later this year.  The expansion will allow the company to accommodate its rapid growth over the last six years, from 682 employees in 2007 to 2 000 today, including more than 1 300 employees in Tarrytown and nearly 600 at its industrial operations and product supply facility in Rensselaer, New York. 

Last November, Regeneron announced plans to invest nearly $70 million in the expansion of its manufacturing site in Rensselaer and create 300 new jobs in the capital region. The company anticipates that with both the Rensselaer and Tarrytown expansions, there will be more than 700 new jobs in New York. Regeneron stated that it will invest approximately $170 million in capital expansion in New York over the next few years. 

Regeneron had also considered expanding outside New York before the State stepped in with $8.5 million in tax credits through the Excelsior Jobs Program. Furthermore, the Town of Mount Pleasant Industrial Development Agency offered additional incentives.  Construction of the new buildings is expected to begin in late 2013 and to be completed in late 2015. 

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.

Regeneron Expands and Creates 400 New Jobs in Westchester

 that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars. The biosimilars arena presents significant opportunities and both companies are set on finding the best routes to realizing the benefits that safe biosimilars of certain biologic pharmaceuticals will bring to the society. 

There is, however, significant regulatory uncertainty with biosimilars at present. Teva and Lonza are, therefore, taking a measured approach. Both companies have agreed to fully evaluate the prevailing regulatory and commercial circumstances before making any further long-term investment decisions on their joint venture. 

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.