pSivida CEO Paul Ashton

pSivida (NASDAQ:PSDV; ASX:PVA) CEO Dr. Paul Ashton will participate today in a panel: New Horizons in Glaucoma Drug Delivery and IOP Monitoring during the Glaucoma 360 New Horizons forum at the Palace Hotel in San Francisco.

The conference is being presented by the Glaucoma Research Foundation in association with Ophthalmology Times to bring together leaders in medicine, science, business, venture capital, and philanthropy, all intent on transforming new ideas into new hope in the worldwide battle to beat glaucoma.”

pSivida is developing a product to treat glaucoma and occular hypertention in collaboration with Pfizer.

Rodman & Renshaw Capital Group (NASDAQ:RODM), via a new subsidiary, DirectMarkets, has unveiled an automated, state-of-the-art electronic transaction platform to directly link existing public company issuers and investors seeking to transact primary offerings of securities.

Both investors and issuers will benefit from 24/7 seamless access to DirectMarkets’ platform through a graphical user interface accessible via computer and mobile smart devices. The official launch will take place at the TradeTech 2012 Conference in New York City that begins on March 6, 2012.

The DirectMarkets platform will empower issuers to sell shares covered by a shelf registration directly into the secondary market and to complete funding transactions at a fraction of the current cost.

Using the same platform, investors will be able to directly contact issuers, with effective shelf registrations in place, to indicate their interest in buying that issuer’s stock, effectively gaining the ability to accumulate stock positions in a more cost-effective manner than through on-going open market purchases.

The DirectMarkets platform is designed to bring greater efficiency and cost savings to current methods that public companies use to effect financings, including follow-on offerings, Registered Directs, At-the-Markets, Confidentially Marketed Public Offerings and Private Investments in Public Equities. DirectMarkets also plans to adapt the platform across international markets.

Rodman has recruited Kevin Lupowitz as CEO of the DirectMarkets operating entity. Mr. Lupowitz was formerly chief information officer of FXall, an electronic foreign exchange platform.

“DirectMarkets will be a game-changer and with Kevin Lupowitz’s talent and experience at the helm, this new electronic transaction platform is the catalyst that will redefine Rodman as an innovative technology company, focusing on the financial services industry, while strengthening our legacy business,” Rodman CEO Edward Rubin said in a statement.

In conjunction with the launch of DirectMarkets, Rodman & Renshaw Capital Group intends to change its name to Direct Markets Holdings, subject to stockholder approval at the annual meeting on May 4, 2012. Rodman’s sales and trading, and investment banking operations will continue to be conducted by Rodman & Renshaw, LLC.

Navidea Biopharmaceuticals (AMEX:NAVB) intends to file a Marketing Authorization Application (MAA) in the EU for Lymphoseek, its radioactive diagnostic tracing agent, based on clinical data accumulated from completed pivotal studies and supporting clinical literature.

Navidea also has been advised by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use that it has adopted the advice of the Scientific Advice Working Party regarding the Lymphoseek development program and has determined that Lymphoseek is eligible for an MAA submission.

Lymphoseek® is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM)

As a result, the company has initiated regulatory activities to submit a MAA to the EMA for Lymphoseek by year-end 2012. The MAA will be similar in scope to Navidea’s New Drug Application submission with the FDA, which has given the company a PDUFA date of June 10, 2012.

Navidea will seek clearance to market Lymphoseek for use in Intraoperative Lymphatic Mapping and will also seek to include the use of Lymphoseek in Lymphoscintigraphy imaging procedures.

“We are pleased to receive the advice and feedback from the [committee and working party] as it provides Navidea with confirmation that our Phase 3 studies were well-designed and, with additional supportive information, provide a strong clinical basis for clearance to market Lymphoseek in the EU,” Rodger Brown, VP of regulatory affairs and quality assurance, said in a statement. “This milestone provides us with a clear pathway for the MAA submission.”

Thomas Tulip, EVP and chief business officer, said Navidea has already engaged a “number of well-known potential commercial partners in discussions and this development will stimulate even more interest in this important, innovative product. We look forward to completing a mutually beneficial arrangement with one or more of these high quality organizations in the coming months.””

CEO Mark Pykett added that the pending MAA submission reflects the company’s belief in the “widespread application and importance of Intraoperative Lymphatic Mapping innovation for those in the EU as a first step in the global registration process for Lymphoseek.”

Roth Capital Partners has upgraded Antares Pharma (AMEX:AIS) to “buy” from “neutral” and raised its 12-month price target to $3.50 from $2, saying the balance sheet is strong and the company could become cash flow positive this year.

“The solid financial position, platform opportunities, and potential for advancement of key products make the stock attractive at current levels,” writes analyst David Moskowitz. The closed at $2.56 on Tuesday.

In late December and January, Antares signed partnership deals with Pfizer and Daewoong Pharmaceuticals, receiving up-front cash from both transactions and royalties on sales of associated products. Antares licensed its overactive bladder gel formulation to Daewoong for sale in Korea and could begin collecting royalties in 2013.

“As a result, and with the potential for the announcement of a new proprietary product candidate later this year, we have increased our value for Antares’ platform and pipeline candidates to $70 million from $40 million,” Mr. Moskowitz said, adding that he believes more platform deals could be announced later this year.

Mr. Markowitz said that assuming Antares and its partner, Teva Pharmaceuticals, win a patent challenge on EpiPen and the FDA approves the company’s product, “we believe sales of branded EpiPen could quickly convert to the generic, and our revenue estimates to Antares could prove conservative.”

Teva continues to develop multiple products using Antares’ proprietary injection device technologies, and “as these candidates advance in development, the chance that Teva could acquire Antares increases,” he said.

In addition, the growth of TevTropin prescriptions is accelerating, “implying potential upside to our long-term expectations for this branded generic product,” he added.

Watson expects to launch its Gelnique line extension based on Antares’ oxybutynin formulation in the second quarter. “In our view, a strong launch could be a catalyst for Antares,” Mr. Markowitz said.

Isotechnika Pharma (TSX:ISA) has exercised its right to terminate an existing development, distribution and license agreement with ILJIN Life Science of South Korea and is pursuing discussions to potentially change the current relationship with ILJIN in order to better advance its voclosporin program.

Isotechnika's voclosporin is a potential breakthrough drug to prevent rejection of a transplanted kidney.

As a result, Isotechnika has secured full rights to voclosporin for transplant and autoimmune indications in the U.S. and other regions outside of Canada, Israel, South Africa, China, Taiwan and Hong Kong. The company already owns full rights in Europe.

Earlier this month, ILJIN, the second largest shareholder of Isotechnika, verbally informed the Isotechnika board that it is planning to “increase their level of control within the company.” The verbal proposal was made by Daniel Park, executive VP of ILJIN, who has resigned his position as chief business officer of Isotechnika, but remains a director.

“In order to have more meaningful discussions with ILJIN, it was determined that the current contract was not appropriate,” Isotechnika CEO Dr. Robert Foster said in a statement.

“Terminating the existing agreement frees the company to engage ILJIN, as well as other companies who have expressed interest in voclosporin,” he added. “This action has given the company the opportunity to secure a new, more favourable, relationship to effectively bring voclosporin to the market.”

BioSante Pharmaceuticals (NASDAQ:BPAX) is evaluating its corporate strategy and has begun to explore new product development projects through in-licensing and mergers and acquisitions.

The company issued a corporate update after two pivotal efficacy trials of its LibiGel testosterone gel for the treatment of female sexual dysfunction failed to achieve statistical significance.

Stephen M. Simes

“We are committed to rebuilding BioSante in order to maximize value for our company and stockholders,” CEO Stephen Simes said in a statement. “Although we are disappointed about the recently reported LibiGel clinical efficacy results, we are optimistic about the future of BioSante.”

In addition to evaluating its corporate strategy, Mr. Simes said BioSante continues to investigate “alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study” and a full review of its GVAX cancer vaccine portfolio is underway.

At the end of 2011, BioSante had about $57 million in cash and cash equivalents and $20.8 million in principal amount of convertible notes outstanding, due on May 1, 2013. The projected burn rate for 2012 is approximately $2.5 million a month, assuming the LibiGel safety study continues.

In order to conserve cash, a reduction of 21 full-time equivalents of employees and contractors has been implemented, representing 25% of BioSante’s headcount. In addition, if the safety study is halted, the monthly burn rate will decline to about $1 million a month, pending other corporate product development and activities.

The company plans to make a decision whether to continue the LibiGel safety study within the next 90 days. Appropriate cost savings have been instituted to minimize the continuing cost of the safety study.

Among other projects, BioSante said the FDA has assigned a PDUFA date of Feb. 14, 2012 for its Bio-T-Gel, a male testosterone gel, which is licensed to Teva Pharmaceuticals USA.

BioSante’s cancer vaccines are being evaluated in 17 Phase 1 and Phase 2 clinical studies and are being funded by various sources, including certain foundations and BioSante licensees. “BioSante’s objective is to help facilitate further studies and commercialization in order to bring important cancer therapies to patients in need and to maximize the value of the cancer vaccine portfolio to BioSante stockholders,” the company said.

Closely held enGene of Vancouver is working on a financing of up to $20 million with venture capital funds to conduct the first two phases of human clinical trials of its intestinal immunotherapy platform to treat ulcerative colitis, a major subtype of Inflammatory Bowel Disease (IBD).

Dr. Anthony Cheung

“We have built significant momentum for the financing in the last two months, and our goal is to put a term sheet in place during the first half of 2012,” interim CEO and co-founder Dr. Anthony Cheung says in an exclusive interview with BioTuesdays.com.

“enGene is working with a number of potential lead institutional investors with deep experience in gastroenterological diseases on a strategy involving a total raise of $20 million, which would suffice to carry us through to completion of a relatively large Phase 2A trial,” he adds.

The company’s plans call for the completion, within 28 months of the closing of the financing, of an initial safety and proof-of-clinical efficacy in a dose escalating, single-dose Phase 1/2A trial for its lead EG-10 product in patients with active ulcerative colitis. This will be followed by a multiple-dose escalating Phase 2A clinical trial within 44 months after the financing is in place.

“Given the novelty of our therapy, which involves delivery of genetic material to patients, clinical testing must be conducted in diseased patients rather than healthy volunteers,” Dr. Cheung points out. “This offers us the opportunity to look for therapeutic effects of our drug even in the first-in-man Phase 1 trial.”

enGene’s EG-10 localizes the delivery of human IL-10 protein to diseased tissue in the intestine via administration of DNA-containing nano­particles to the colon. IL-10 is a naturally occurring protein in the body with a well-established role in suppressing inflammation and promoting immune tolerance.  Previous large-scale clinical trials conducted by Schering-Plough demonstrated promising therapeutic efficacy in humans with IBD, using low doses of injectable recombinant IL-10 protein. However, its effectiveness was limited by excessive systemic adverse drug effects at higher doses.  The short half-life of recombinant IL-10 in the bloodstream is also a significant limiting factor for its clinical success.

Therapeutic efficacy of EG-10 in IBD mouse models

EG-10 is designed to address these limitations specifically.  The company has proven in animal models that EG-10 effectively concentrates IL-10 proteins in the intestine, while limiting wider, systemic protein drug distribution, which greatly improves the safety and efficacy of IL-10.  Moreover, therapeutic efficacy of EG-10 has been demonstrated in multiple animal models of IBD.

IBD is a chronic and debilitating disease affecting over 1.6 million people in North America and over four million worldwide. The disease is sub-categorized into ulcerative colitis and Crohn’s disease; both are chronic conditions requiring lifelong treatment. Global annual sales of biologic drugs to treat IBD totaled $4 billion in 2010 and are forecast to reach $5.6 billion by 2019.

enGene’s initial human studies will be conducted in Canada with several world class clinical investigators in the field of IBD at the Robarts Clinical Trials at the University of Western Ontario and at the University of Alberta. Clinical testing beyond Phase 2A will likely incorporate U.S. and European clinical sites, according to Dr. Cheung.

Last week, enGene established a clinical advisory board, consisting of several world-leading clinical investigators in the field of IBD:  Drs. Brian Feagan of Robarts, Richard Fedorak of the University of Alberta, Geert D’Haens of the University of Amsterdam and Scott Plevy of the University of North Carolina.

The intestine is the largest immune organ in the body, where over 70% of the body’s immune cells are found. “Recent groundbreaking research has revealed that critical immune cells, which control certain autoimmune diseases, including IBD, Type 1 diabetes, multiple sclerosis, celiac disease and rheumatoid arthritis, are regulated in the intestine,” Dr. Cheung said.  He adds that IL-10 also has been shown to be a “crucial suppressor of these culprit immune cells in the intestine.”

enGene's technology offers multiple opportunities

This new research provides a strong rationale for enGene to develop its EG-10 product into a mucosal immunotherapy platform.  The company intends to modify EG-10 to target other immune disorders, such as Crohn’s disease, Type 1 diabetes, and celiac disease, once safety and pharmacodynamics are established in the Phase 1/2A clinical trial for ulcerative colitis.

“However, the money we’re raising now will only be used to advance the development of EG-10 for ulcerative colitis,” he says.

The company already has demonstrated that gut-localized delivery of IL-10 resulted in changes in overall intestinal and systemic immunity, which ultimately led to significant therapeutic improvement in several animal models of autoimmune diseases, including IBD and Type 1 diabetes.

“We are the only company in the world that has the proven capability to effectively deliver DNA to the gut mucosa,” Dr. Cheung contends.  “With the increasing appreciation that the intestine controls the pathogenesis of multiple autoimmune diseases, enGene’s robust nucleic acid delivery system optimized for the intestinal tract offers a new therapeutic approach to deal with various diseases of the immune system,” he adds.

“Our proprietary technology is comprised of extremely small particles carrying a therapeutic nucleotide—either DNA or siRNA—which we encase in a proprietary formulation consisting of a biocompatible polymer called chitosan.  These nanoparticles are designed to protect the payload and facilitate efficient uptake by mucosal cells,” Dr Cheung explains.

enGene’s technology is covered by a family of over 30 issued and filed patents. The company is also developing a formulation for oral delivery of its products to augment its current delivery technology.

enGene was originally founded to develop a way of systemically delivering insulin from the gut. “Through that process, we became experts at delivering genes to gut cells,” Dr. Cheung says. The company has advanced its EG-02 candidate as a meal-regulated insulin replacement therapy through dosing studies in large animal models and is now in partnership discussions that could produce a deal later this year, he adds.

The company also has adapted its formulation chemistry for the delivery of small-interfering RNA (siRNA) to mucosal tissues, such as the lung, uterus and gut, and has established a partnership with a large pharma­ceutical company to use its formulation to deliver siRNA.

“We’re not putting a lot of financial investment into this area at this point,” Dr. Cheung says. “But what we bring to the table for our partner is a great deal of know-how and intellectual property about how to formulate nanoparticles for delivering siRNA to various mucosal tissues. Our partner is screening the formulation in animal models, and in six to seven months, if the data are promising, there could be a significant partnership deal for enGene.”

Health Canada has accepted for review a New Drug Submission by Cipher Pharmaceuticals (TSX: DND) for its CIP-Isotretinoin, a novel, patented formulation of the acne medication isotretinoin. The company expects a response from Health Canada in the first quarter of 2013.

“Health Canada’s acceptance moves us a step closer to the commercialization of CIP-Isotretinoin in Canada,” CEO Larry Andrews said in a statement. “It has been our strategic intent to capitalize on this product’s potential in markets beyond the U.S., and we believe there is a meaningful opportunity in Canada.”

The acne treatment is also under review by the FDA.

Cipher’s fenofibrate formulation is marketed in the U.S. as Lipofen. Its extended-release tramadol is marketed in the U.S. as ConZip and will be marketed in Canada as Durela.

Roth Capital Partners has upgraded Spectrum Pharmaceuticals (NASDAQ:SPPI) to “buy” from “neutral” and raised its 12-month price target to $20 from $11, citing an increasing focus on revenue and data catalysts in 2012. The stock was quoted at $13.93 Thursday afternoon.

“We base our upgrade on our belief that Fusilev revenue will remain strong at least through the first half of 2012, anticipated pivotal data catalysts in the first half for apaziquone and belinostat, and anticipated growing exposure of the Zevalin franchise,” writes analyst Joseph Pantginis.

He expects NDA submissions this year for apaziquone in bladder cancer and belinostat in peripheral T-cell lymphoma.

Yesterday, Spectrum announced that it had acquired the non-U.S. rights to Zevalin to complement its U.S. rights, paying Bayer about $25 million, with an undisclosed royalty on non-U.S. Zevalin sales, which Mr. Pantginis figures are in the high single digits.

Based on the demonstrated efficacy and enhanced treatment convenience of only one infusion, Zevalin could experience a stronger “push” into the U.S. market and threaten Roche’s Rituxan market share, Mr. Pantginis added.

In 2013, he said Spectrum could have four marketed products and demonstrate progress with its earlier- stage pipeline.

Navidea Biopharmaceuticals (AMEX:NAVB), formerly Neoprobe,  has entered into a six-month option agreement with Alseres Pharmaceuticals to license [123I]-E-IAFCT Injection, also called Altropane, an Iodine-123 radio-labeled imaging agent, being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders.

“Should we exercise the option, [123I]-E-IAFCT would provide us not only with another strong Phase 3 diagnostic imaging asset, but also one that has great synergy with our AZD4694 PET imaging agent, which we are developing as an aid in the diagnosis of Alzheimer’s disease,” Dr. Thomas Tulip, EVP and CBO of Navidea, said in a statement. “Together, we believe these programs provide us with a robust franchise in precision neuro-imaging diagnostics.”

If the companies enter into a definitive license agreement, Alseres would receive 400,000 shares of Navidea common stock. The accord also includes contingent milestone payments of up to $3 million, $2.75 million at the time of product registration or commercial sales, and the issuance of up to an additional 1.05 million shares of Navidea stock, 950,000 shares of which are issuable at the time of product registration or commercial sales. Royalties on net sales of the approved product are consistent with industry-standard terms.

[123I]-E-IACFT has been administered to over 600 subjects to date. A Phase 3 Special Protocol Assessment is already in place with the FDA and over 50 subjects have been enrolled to establish a training data base.

Results from clinical trials have demonstrated that [123I]-E-IACFT has a high affinity for the dopamine transporter and rapid kinetics, which enable the generation of clean images, beginning within about 20 minutes after injection. Other agents typically have waiting periods from four-to-24 hours before imaging can occur.

In addition to its potential use as an aid in the differential diagnosis of Parkinson’s disease and movement disorders, [123I]-E-IACFT may also be useful in the diagnosis of Dementia with Lewy Bodies, one of the most common forms of dementia after Alzheimer’s disease.

“The [123I]-E-IACFT program is consistent with our strategy to build our precision radiopharmaceutical pipeline with later stage, high value diagnostics aimed at important unmet medical needs,” CEO Dr. Mark Pykett said. “We believe this program represents an excellent strategic fit for us at this time.”