8/23/2011

Intellipharmaceutics & Par Pharmaceutical Expand Development & Commercialization Agreement

Intellipharmaceutics International Inc. recently announced that they have added the development and commercialization of additional strengths of generic Focalin XR (dexmethylphenidate hydrochloride) for the US market to their existing agreement with Par Pharmaceuticals, which applied to the development and commercialization of the 5-, 10-, 15-, and 20-mg strengths of generic Focalin XR.

Under the terms of the expanded agreement, Intellipharmaceutics will receive an immediate cash payment from Par and will continue to receive a share of profits from future sales. According to Wolters Kluwer Health, US sales of Focalin XR, used in the treatment of Attention Deficit Hyperactivity Disorder, were approximately $536 million for the 12 months ending June 2011. Five strengths (5, 10, 15, 20, and 30-mg) of a generic version of Focalin XR are currently the subject of Intellipharmaceutics’ pending ANDA with the FDA.

Intellipharmaceutics and Par are parties to a settlement of their earlier US litigation against Novartis Pharmaceuticals Corporation, Elan Pharma International Ltd., and Celgene Corp. with respect to the 5-, 10-, 15-, and 20-mg products, the terms of which are confidential. Intellipharmaceutics and Par are currently defendants in on-going US litigation against the same plaintiffs in regard to the 30-mg product.

“We are extremely pleased with the expansion of the agreement we currently have in place with Par for the development and commercialization of generic Focalin XR,” commented Dr. Isa Odidi, CEO of Intellipharmaceutics. “Today’s announcement adds further credibility to the quality of our work and the growth of our company.”

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development, and manufacture of novel or generic controlled-release and targeted-release oral solid dosage drugs. The company’s patented Hypermatrix technology is a unique and validated multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals.

Xcelience to Expand, Plans to Hire 45 Employees

Xcelience, a Tampa, FL-based contract research organization, recently announced it is expanding its footprint and more than doubling its employment over the next 3 years.

“We have weathered the economic crisis and feel honored by the confidence our long-term clients have shown in us throughout. Now, as our business experiences a strong rebound, we are poised to ensure that we have the capacity and staff to maintain the highest level of quality for our rapidly expanding customer base,” said CEO and President Derek Hennecke.

Tampa Mayor Bob Buckhorn applauded the expansion as a boost to local efforts to grow the Tampa Bay area’s biotechnology industry.

“Xcelience’s expansion further demonstrates that Tampa is the perfect environment to successfully start and grow biotech companies,” said Mr. Buckhorn. “We are extremely proud to join in today’s announcement and look forward to the company’s continued success.”

Xcelience will be expanding its 24,000-sq-ft existing facility with the addition of nine rooms (1,000 sq ft), as well as developing a new 24,000 sq-ft facility a short distance away to help accommodate 45 new employees. The new jobs made the company eligible for a Florida Qualified Targeted Industry Tax Refund incentive award of $135,000. To qualify for QTI, the new jobs must pay average salaries meeting or exceeding 115% ($46,833) of the Tampa-St. Petersburg-Clearwater MSA’s average annual wages.

“Xcelience’s expansion is great news for the state of Florida as well as for Tampa,” says Enterprise Florida President Gray Swoope. “It demonstrates the successful outcomes we’re achieving toward job creation, thanks to strong partnerships between our local communities and the business, economic development, and government sectors.”

Xcelience’s headquarters is located in Tampa, where there is a good base of talented workforce to build upon. “Our goal is to remain in this community”, says Mr. Hennecke. “We are excited to be a part of the local economic turn-around that we see beginning to occur in the Tampa Bay area.”

Hillsborough County Commission Chairman Al Higginbotham thanked the company for expanding in Tampa and says, “We welcome Xcelience’s news of its expansion within Hillsborough County, and look forward to many years of future success from this good corporate neighbor. Nurturing the life sciences industry and support for firms, such as Xcelience, will provide dividends to our economy and quality job opportunities for our citizens.”

Xcelience is poised to begin hiring, and is currently seeking Chemist-II and Manager positions for Preformulation/Formulation. Jobseekers may find more information and apply for open positions on the Xcelience website at www.xcelience.com/formulation-development-careers/.

Xcelience wishes to recognize each of these important institutions for the role they play in stimulating sustainable capital investment in the Florida community. Harak Associates, a local incentives management consulting firm, is an excellent resource for companies needing assistance with applications and reimbursement processes for state, regional, and local tax and training grant incentive programs. The Tampa Hillsborough Economic Development Corporation is officially designated by Enterprise Florida as Hillsborough County‘s primary business recruitment economic development team. The EDC partners with Hillsborough County and the cities of Tampa, Plant City, Temple Terrace, and private Investors. Its primary mission is to create jobs that pay above average wages and to broaden the tax base by generating new, sustainable capital investment.

Encap Drug Delivery Introduces Colon-Screen

Encap Drug Delivery recently announced it is now offering a feasibility package that will evaluate the potential to use candidate compounds in formulations suitable for oral delivery to the colon. This will involve the use of the Phloral coating technology developed by the London School of Pharmacy. This new technology represents a significant improvement in colonic delivery, providing fail-safe delivery of drug to the target site by employing two complementary mechanisms to trigger drug release. As well as a pH-dependent coating, it also incorporates a resistant starch component that is broken down specifically by the microbiota in the colonic region.

Recently, colonic drug delivery has gained increased importance, not just for treatment of local diseases associated with the colon, eg, Crohn’s disease, ulcerative colitis, colorectal cancer, and irritable bowel syndrome (IBS), but also for its potential as a site for the absorption of certain molecules due to the decreased levels of efflux transporters and membrane-bound metabolic enzymes known as cytochromes. Its potential suitability for the oral delivery of peptides and proteins, oligonucleotides, and vaccines is also an area of increasing interest.

Existing colonic systems generally involve coating the dosage unit with polymeric materials that will not normally dissolve in the low pH of the stomach or upper intestine but will dissolve in the higher pH of the lower intestine. Coatings that rely on a pH-dependent system have the potential to be unreliable due to the large intra- and inter-patient variability in transit times and luminal pH.

One of the drawbacks to colonic delivery is the relatively low amount of water that is available for dissolution of dosage forms in this part of the gastrointestinal tract. The combination of a reliable colonic targeting technology and the delivery of drugs in a liquid dosage form using Encap’s liquid fill technologies should provide a significant advance for the oral delivery of a wide range of drugs to the colon.

Encap now offers clients a feasibility package that will evaluate the potential to use candidate compounds in liquid fill formulations suitable for delivery to the colon. There are four stages to this screening process:

Prototype Formulation Evaluation: Studies are conducted to determine the feasibility of formulating the drug candidate in a stable dosage form. Prototype formulations are developed by incorporating the drug into vehicles that are suitable for liquid fill.

Assessment of the Stability of the Test Compound to Metabolism by Colonic Bacteria: The microbiota of the large intestine has the capacity to ferment or metabolise a large variety of molecules, which has implications for drug stability and may preclude colonic delivery for certain compounds. Drugs reaching the colon by virtue of poor solubility or the use of modified-release dosage forms are particularly at risk. In this study, the candidate compound stability will be investigated in buffered fecal slurry that simulates the conditions of the lower gut.

Dissolution Testing: Capsules are tested to ensure coating integrity and to predict in vivo drug-release profiles for each prototype formulation. Prototype capsules must demonstrate resistance to the stomach, resistance to the upper GI tract, and finally release the contents into colon.

PK Study (Optional): The Phloral coating is designed for use in the human colon; however, it is recognized that clients may wish to generate preclinical data before progressing to human studies. In this optional study, the prototype formulation(s) will be administered to animals in a simple exploratory PK study. The data obtained will provide a quantitative measure of drug exposure in order to interpret preclinical efficacy.

This straightforward package of studies will allow companies to quickly test the suitability of delivering their compound to the colon as an oral dosage form.

Evonik Establishes New Health Care Business Line

Evonik Industries AG recently announced it will combine its business in custom manufacturing of APIs (exclusive synthesis), pharmaceutical amino acids (Rexim) and pharmaceutical polymers in the new Health Care Business Line effective September 2011. The newly formed business line will be part of the Health & Nutrition Business Unit, headed by Dr. Reiner Beste.

“The merger strengthens our distribution, research, technical service, and production network. This means our products and services will be equally represented in key pharmaceutical markets in Europe, America, and Asia, and that we can respond more comprehensively to customer requirements,” explained Dr. Beste.

Success factors for specialty chemical companies in the pharmaceutical market include global market access, a broad innovation platform, and production in accordance with the cGMP pharmaceutical standard.

“By concentrating our pharmaceutical activities in the Health Care Business Line, we enhance our performance in all three areas,” noted Dr. Beste. “This creates the framework for further strategic developments and the targeted advancement of partnerships with key customers.”

The Health Care Business Line will be divided into three product lines: Pharma Polymers with the brands EUDRAGIT and RESOMER under the management of Dr. Thomas Riermeier, Exclusive Synthesis under the management of Dr. Klaus Stingl, and Rexim under the management of Dr. Thomas Hermann.

The Pharma Polymers Product Line is a leading developer and manufacturer of functional pharmaceutical excipients for oral and depot formulations and a provider of solutions to the healthcare industry for drug and medical device functionality. The Pharma Polymers portfolio includes acrylic copolymers marketed under the brand name EUDRAGIT, bioresorbable poly(lactic-co-glycolic acid) copolymers marketed under the brand name RESOMER as well as advanced formulation services for oral and parenteral dosage forms.

The Exclusive Synthesis Product Line focuses on the manufacture of custom-tailored, high-quality advanced GMP-intermediates and patented API and high-potency APIs (HPAPI) for the pharmaceutical industry, from clinical stage all the way to commercialization. The global production and research network of the product line offers a seamless service portfolio, ranging from the development of syntheses at the laboratory-scale to commercial-scale production in facilities certified by the US FDA.

The Rexim Product Line is a significant producer of amino acids, peptides, and amino acid derivatives, supplied in pharmaceutical and food-grade qualities. These products are primarily used in the pharmaceutical industry, including in infusion solutions, in cell cultures, and to manufacture APIs for the treatment of high blood pressure and diabetes, but also have applications in the cosmetics and food industry. The strengths of Evonik include its global distribution network and cGMP-compliant manufacturing across the entire supply chain, ranging all the way to cGMP-compliant amino acid purification.

DARA BioSciences Receives Fast-Track Designation for KRN5500

DARA BioSciences, Inc. recently announced its investigational drug KRN5500 has been granted Fast-Track designation by the US FDA for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

DARA earlier reported positive results of its Phase II clinical trial (DTCL100), which met its primary endpoints of reduction of pain and safety and was superior to placebo (p = 0.03). Based largely on these positive findings, the National Cancer Institute (NCI) is partnering with the company to initiate a second Phase II study, which it anticipates will commence later this year.

“We see a lot of patients with chemotherapy-induced neuropathic pain,” said Amy P. Abernethy, MD, Director of the Duke Cancer Care Research Program at the Duke University Medical Center. They are a group of people that I find personally distressing to treat because they’ve got such difficult problems, and many of them actually have long lives ahead of them, but have severe pain problems. No matter where they are in the course of their illness, I think that KRN5500 holds promise as a potential help.”

“The FDA Fast-Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy,” said Richard A. Franco, RPh, Chairman and CEO of DARA BioSciences. “This is a most serious condition in need of new treatment options. Current estimates show as many as 40% to 50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI), and now the FDA Fast-Track Drug status.”

Alexza Pharmaceuticals Announces PDUFA Goal Date

Alexza Pharmaceuticals, Inc. recently announced the US FDA has accepted the ADASUVE NDA as a complete, class 2 response to the FDA’s action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012. On August 4, 2011, Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.

Alexza’s NDA is based on a comprehensive clinical development program including two positive Phase III clinical trials. In addition to the data from the original NDA and supplemental analyses of some of these data, the ADASUVE resubmission contains new data from a successfully completed human factors study, stability data from new production batches manufactured in late 2010, updated manufacturing and controls sections addressing findings from the company’s Pre-Approval Inspection, and updated draft labeling and a comprehensive Risk Evaluation and Mitigation Strategy (REMS) proposal.

“If approved, ADASUVE would be the first drug marketed based on the novel Staccato technology platform,” stated Thomas B. King, President and CEO of Alexza. “We believe ADASUVE can offer physicians and patients a new therapeutic option, which combines rapid onset of action and reliability of medication delivery in a non-invasive formulation that is easy to administer. These are the key attributes outlined by the American Association for Emergency Psychiatry for the treatment of behavioral emergencies.”

Agitation can occur in many people suffering from major psychiatric disorders, including schizophrenia, which affects approximately 2.4 million adults in the US, and bipolar disorder, which affects approximately 5.7 million adults in the US. More than 90% of these people will experience agitation in their lifetime. Agitation generally escalates over a short period of time with patients initially feeling uncomfortable, tense, and restless. As the agitation intensifies, their behavior appears more noticeable to others as they become threatening and potentially violent, especially if the agitation is not treated. Agitation episodes are currently most often treated with antipsychotics and/or benzodiazepines in oral or intramuscular injection preparations. However, there are no non-invasive therapies that work within 30 minutes to help agitated patients in need of treatment.

ADASUVE is an anti-agitation product candidate that combines Alexza’s proprietary Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable to intravenous administration, but with greater ease, patient comfort, and convenience. In clinical studies, ADASUVE has shown an onset of effect in 10 minutes of dosing, which is the first time point measured in the Phase III clinical studies. The ADASUVE NDA contains efficacy and safety data from more than 1,600 patients and subjects who have been studied in 13 different clinical trials.