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Avanir Pharmaceuticals, Inc. is a biotechnology company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders.  Our lead product, NUEDEXTA, is a dual sigma-1/NMDA receptor modulator and is the first and only FDA-approved treatment for pseudobulbar affect (PBA).  PBA is a condition affecting many patients with Alzheimer's / dementia, stroke, MS, Parkinson's, and other forms of neurological disease or injury and is characterized by uncontrolled episodes of crying or laughing.  

Avanir is commercializing NUEDEXTA in the United States through its specialty sales force calling primarily on neurology and psychiatry clinics as well as nursing homes.  Recent commercial milestones include over 10,000 Rx's during the month of August 2012 (up 9% relative to the prior month), which equates to a gross NUEDEXTA sales run-rate of over $65 million per year.

Avanir has a pending MAA for NUEDEXTA with the European regulatory authorities and is also conducting clinical trials in additional indications such as agitation in dementia, neuropathic pain in multiple sclerosis, and other areas where dual sigma-1/NMDA receptor targeted therapies can address unmet needs.    

Teikoku Pharma USA Inc., a wholly-owned subsidiary of Teikoku Seiyaku Inc. of Japan, is an international specialty pharmaceutical company that develops, and manufactures pharmaceutical products. Teikoku focuses its efforts in three therapeutic areas; Pain Management, CNS and Oncology.  Teikoku's main product is Lidoderm® (Lidocaine 5% Patch) for PHN, distributed by Endo Pharmaceuticals in the US, Grunenthal GmbH in Europe. Our core technology platforms include; passive and active transdermal delivery systems as well as injectables. We are currently actively seeking to in-license/acquire later stage product for the US, Europe and Japan.

Novartis Oncology profile

 A business unit within the Novartis Group, Novartis Oncology delivers a broad range of innovative therapies and practical solutions that help change the way patients live with cancer and blood disorders. Glivec® (imatinib) is an oral treatment for multiple rare diseases including forms of Philadelphia-chromosome positive (Ph+) chronic myeloid leukemia (CML) and Kit (CD117)-positive gastrointestinal stromal tumors (GIST). Tasigna® (nilotinib) is approved for Ph+ CML adult patients resistant to or intolerant to at least one prior therapy. Afinitor® (everolimus) is indicated for patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapy. Zometa® (zoledronic acid) is indicated for the prevention of skeletal-related events in patients with advanced malignancies involving bone. Zometa also treats hypercalcemia of malignancy. Femara® (letrozole) is approved for adjuvant treatment of hormone receptor positive early breast cancer as well as for extended adjuvant treatment of hormone receptor positive early breast cancer after five years of initial tamoxifen therapy. It is also approved for several uses in certain postmenopausal women with advanced breast cancer. Sandostatin® LAR® (octreotide) helps control symptoms, such as severe diarrhea and flushing, associated with functional gastroenteropancreatic neuroendocrine tumors. It is also approved for the treatment of acromegaly. Exjade® (deferasirox) is approved to treat iron overload in a broad range of patients receiving ongoing blood transfusions. Novartis Oncology has a robust pipeline that utilizes recent discoveries in molecular genomics, rational drug design and state-of-the-art drug discovery technologies.

Partnering strategy

Novartis Oncology is seeking to license or acquire targeted therapeutic approaches to cancer treatment, with a particular interest in projects that have demonstrated Proof-of-Concept in human trials.

Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary products principally for use in the hospital setting with a current focus on already marketed or near to market hospital products.

Cadence has a highly experienced commercial group of 140+ hospital sales specialists, 14 MSLs and marketing team which are focused entirely on promotion to the hospital in the United States.  Our sales force is currently promoting OFIRMEV™ (acetaminophen injection), which is indicated for the treatment of acute pain and fever and we are now looking to expand our product offering.

Clinical stage biotech with a solution for gene/protein delviery to cancer cells.

Tocagen is a private biopharma developing a unique retroviral replicating vector (RRV) platform that can efficiently delivery a gene or protein of choice selectively to cancer cells.

·         A fundamental challenge in oncology is to selectively deliver active agents to cancer cells while sparing healthy tissue.  We believe we may have found a solution.
·         Unlike oncolytic viruses, RRVs are unique because they replicate by budding-off from the host cancer cell which allows "stealth" spread through cancer tissue without being cleared by the immune system.
·         Our RRV system is capable of delivering genes such as those that code for prodrug activator enzymes, shRNA, or therapeutic proteins.
·         Our lead RRV product candidate, Toca 511, delivers a prodrug activator gene, cytosine deaminase (CD), selectively to cancer cells.
·         Toca 511 is used in combination with Toca FC, a proprietary formulation of 5-FC, that is converted in the presence of CD in infected cancer cells to 5-FU.
·         To date, Toca 511 & 5-FC has been dosed in 36 patients with high grade glioma in two ascending dose Phase I trials.
·         In addition to a promising safety and efficacy profile in patients, we have also accumulated data in patients supporting the anticipated mechanism of action for this approach
·         Now that we have clinical validation for our technology platform, we are interested in partnership discussions e.g. building new RRV constructs for the delivery of a gene or protein of interest to the partner.

More details about our technology can be found at www.tocagen.com and more information about our clinical trials can be found here: http://clinicaltrials.gov/ct2/results?term=tocagen

Mallinckrodt, the pharmaceuticals business of Covidien, is a vertically integrated leader in providing products used in diagnostic procedures and in the treatment of pain and related conditions.  Covidien announced last December that they are spinning off Mallinckrodt into a stand-alone company, a process that is expected to be completed in mid-2013.  Mallinckrodt is the largest US supplier, by prescription, of opioid pain medications and a leading manufacturer of active pharmaceutical ingredients. It is also the largest US supplier of the medical isotope technetium-99m and an industry leader in radiopharmaceuticals and contrast media and delivery systems.  Sales in 2011 were $2.0 billion. Please visit www. mallinckrodt.com to learn more about our business.  The company’s branded pharmaceuticals portfolio includes EXALGO® (hydromorphone HCl) Extended-Release Tablets (CII) and PENNSAID® (diclofenac sodium topical solution) 1.5% w/w.  In June 2012, Mallinckrodt entered into agreements with Horizon Pharma and Zogenix Inc. to co-promote their branded pharmaceuticals for rheumatoid arthritis and acute migraine, respectively.  In August 2012, the FDA approved the 32 mg tablet strength of EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII).  Mallinckrodt is primarily pursuing acquisition or licensing deals for pharmaceuticals which are either in late stage development or are approved for commercialization.

Our strategy is to selectively collaborate with leading companies with the resources and capabilities to assist us in developing and commercializing some of our product candidates, particularly in target indications for which our collaborator has significant expertise or that involve large primary care markets. We generally seek co-promotion or co-commercialization rights in alliances.

We have a collaboration with AstraZeneca focused in cognitive disorders that includes AZD-3480 and AZD-1446.  We have the option to co-promote  certain compounds licensed under our cognitive disorders agreement to selected specialist physicians in the US.

 We are currently interested in exploring alliances or collaborations for:

• TC-5619, which is in on-going Phase 2 trials in negative symptoms of schizophrenia and ADHD predominantly inattentive subtype; • TC-6499, which in a Phase 2a study showed encouraging potential to enhance GI motility relevant to treating GI/GU disorders such as diabetic gastroparesis and IBS-C/CIC; and • Targacept’s Parkinson’s disease/levodopa-induced dyskinesia program to exploit NNR Therapeutics for symptomatic treatment and disease modification.

We are receptive to evaluating clinical-stage CNS, GI/GU or Orphan opportunities to complement our pipeline.