Aegerion Pharmaceuticals & QLT Agree to Strategic Merger


Aegerion Pharmaceuticals, Inc. and QLT Inc. recently announced they have entered into a definitive merger agreement under which Aegerion will be merged with a wholly owned indirect subsidiary of QLT. Upon completion of the proposed merger, each outstanding share of Aegerion common stock will be exchanged for 1.0256 shares of QLT common stock. QLT plans to change its name upon the closing of the proposed transaction to Novelion Therapeutics Inc., and its common shares will trade on the NASDAQ Global Select Market and the Toronto Stock Exchange.

A broad-based investor syndicate composed of both new investors and existing shareholders of both companies (collectively, the Investors) has committed to invest approximately $22 million in QLT and to vote in favor of the proposed transaction. This investment would be funded immediately prior to the transaction close and is expected to provide Novelion with additional capital to support future operations and the potential opportunity for targeted business development initiatives. Assuming completion of the proposed merger by the end of the third quarter of 2016, Novelion is expected to have an unrestricted cash balance of over $100 million.

The proposed transaction, which has been approved by the Boards of Directors of both companies, is expected to close late in the third quarter or during the fourth quarter of 2016, subject to approval by shareholders representing a majority of the outstanding common stock of each of QLT and Aegerion as well as other closing conditions.

The proposed merger is expected to create a strong, rare disease-focused global biopharmaceutical company with a diversified portfolio consisting of Aegerion’s two commercially branded products, Juxtapid (lomitapide) capsules and Myalept (metreleptin), and QLT’s QLT091001 (Zuretinol Acetate or Zuretinol), a Phase III-ready Ultra-Orphan Fast Track and Orphan Drug designated asset being developed for the treatment of Inherited Retinal Disease caused by underlying mutations in RPE65 or LRAT genes (IRD), which indication comprises Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP).

“We believe QLT’s clinical development team, and meaningful cash position, and Aegerion’s commercialization expertise will help unlock significant value in QLT’s Zuretinol asset and enable Novelion to pursue important milestones across a commercial and late-stage portfolio, including potential regulatory approval in Japan for Juxtapid and potential regulatory filings in Europe for Myalept,” said Aegerion’s Chief Executive Officer, Mary Szela, who will serve as Chief Executive Officer of Novelion following the close of the transaction. “I believe that this proposed merger represents a fresh start and an opportunity to create significant value, and I look forward to driving our programs forward.”

“Given the resource requirements for QLT to build out a global commercial infrastructure designed to most effectively maximize the value of our promising ultra-orphan Zuretinol asset, the QLT board determined that it would be advantageous to join forces with a strategic partner possessing the relevant orphan product infrastructure. We believe Aegerion and QLT are ideal complements, and we are confident that this transaction achieves virtually all of the principal goals and objectives of our strategic review process. In addition, QLT is expected to benefit from greater scale and diversification, as well as from a more liquid stock,” added Geoffrey F. Cox, PhD, QLT’s Interim Chief Executive Officer.

QLT is developing a synthetic retinoid product candidate (Zuretinol acetate) for the potential treatment of Inherited Retinal Disease caused by underlying mutations in RPE65 or LRAT genes (IRD) that prevent adequate functioning of the retinoid cycle, which indication comprises LCA and RP. LCA and RP are two forms of severe IRD resulting in progressive vision loss starting in childhood and leading to inevitable blindness.

There are currently no US FDA- or European Medicines Agency- (EMA) approved pharmacologic treatments for either LCA or RP, underscoring the significant unmet medical need. Zuretinol acetate is expected to advance to Phase III clinical trials in the third quarter of 2016 and has Orphan Drug designation from both FDA and EMA, as well as FDA Fast Track designation. As an oral product, Zuretinol acetate is being studied for its potential to treat the retinas of both eyes simultaneously. If approved, QLT believes it is possible to achieve first-line positioning in the treatment of IRD.

In combination with the proposed merger transaction, a broad-based investor syndicate will subscribe to purchase approximately $22 million in shares of QLT common stock for a purchase price of $1.76 per share is subject to the satisfaction or waiver of the conditions to closing the merger. These commitments would be funded immediately prior to merger closing to provide Novelion additional capital to support future operations and the potential opportunity for targeted business development initiatives.
The investor syndicate includes new investors, including Deerfield, and a broad group of existing Aegerion and QLT shareholders, including Armistice Capital, Broadfin Capital, Healthcare Value Capital, JW Asset Management, K2 & Associates Investment Management, Sarissa Capital, Tiger Legatus Capital Management, and others.
The subscription by the Investors to purchase shares of QLT common stock is subject to the satisfaction or waiver of the conditions to closing the merger. Each of the Investors has also agreed to vote its shares in QLT and Aegerion in favor of the transaction.

Following the close of the transaction, Novelion is expected to have its principal headquarters in Vancouver, British Columbia, where QLT is currently located, with business operations in Cambridge, Massachusetts.

The Board of Directors of Novelion will be comprised of 10 members, including four QLT designees, four Aegerion designees and two shareholder representatives, one from Broadfin Capital and the other from Sarissa Capital. For a period of time that expires shortly after Novelion’s 2017 annual shareholder meeting, Sarissa Capital also has the right to designate an additional director to the Novelion Board.

Under the terms of the merger agreement, Aegerion will become a wholly owned indirect subsidiary of QLT, and each existing share of Aegerion common stock will be converted into the right to receive 1.0256 common shares of Novelion. As a result of the structure of this transaction, a repayment obligation with respect to Aegerion’s outstanding convertible notes will not be triggered.

The exchange ratio for the transaction is subject to certain adjustments if Aegerion’s previously disclosed securities class action litigation and Department of Justice (DOJ) and Securities and Exchange Commission (SEC) investigations are resolved prior to closing for amounts in excess of negotiated thresholds. In the event the class action litigation or DOJ and SEC investigations are not settled prior to closing, and in order to mitigate the risk of certain losses from these outstanding matters after transaction close, QLT will enter into a warrant agreement pursuant to which warrants will be issued to QLT shareholders and the Investors that would be exercisable for additional Novelion shares if the class action litigation or DOJ and SEC investigations are subsequently resolved for amounts in excess of negotiated thresholds.

Following completion of the proposed merger, QLT shareholders, including the Investors, who are investing in QLT immediately prior to closing, are expected to own approximately 67% and current Aegerion shareholders will own approximately 33% of Novelion’s common shares.

Concurrent with signing, Aegerion and QLT have entered into a loan agreement under which QLT has agreed to loan Aegerion up to $15 million for working capital. Aegerion will borrow $3 million in connection with execution of the Merger Agreement and may borrow up to $3 million per month in subsequent months, subject to certain conditions, if and to the extent such amounts are necessary in order for Aegerion to maintain an unrestricted cash balance of $25 million.

In addition to shareholder approval, the merger is subject to stock exchange approvals and other closing conditions, including, among others, regulatory approval and completion of a specified minimum of the private placement in QLT by the Investors.
Greenhill & Co., LLC is acting as the exclusive financial advisor to QLT and Weil, Gotshal & Manges LLP is serving as QLT’s legal counsel. J.P. Morgan is acting as the exclusive financial advisor to Aegerion and Ropes & Gray LLP is serving as Aegerion’s legal counsel.

Cellectar Biosciences Announces Results of Tumor-Targeting Study

Cellectar Biosciences, Inc. recently announced the results of a preliminary tumor-targeting study that shows its prototype paclitaxel chemotherapeutic conjugate, CLR 1602, may be up to 30 times more tumor selective in comparison to free paclitaxel.

The preliminary in vivo study demonstrated that tumor uptake of CLR 1602’s paclitaxel payload increased by more than 30-fold over free paclitaxel, and also displayed an extended plasma half-life relative to free paclitaxel. The extended plasma half-life may, in part, explain the enhanced tumor uptake. Unlike free paclitaxel, which was rapidly cleared from plasma within 24 hours, CLR 1602 displayed prolonged retention even at 96 hours.

“The study results are a significant signal in the development of our paclitaxel Phospholipid Drug Conjugates (PDCs). More importantly, it represents further validation of our entire CLR CTX program,” said Jim Caruso, President and CEO of Cellectar Biosciences. “These data clearly confirm our ongoing assertion that delivery of chemotherapeutics with our PDC platform may provide superior tumor cell targeting than chemotherapeutics alone, converting non-targeted chemotherapeutics into targeted cytotoxic agents. We anticipate conducting future studies and evaluating against other comparators, such as Abraxane.”

The study was designed to assess the pharmacokinetics, absorption, and distribution after a single intravenous administration of CLR 1602, (N=24) a paclitaxel PDC vs. free paclitaxel (N=24) in tumor bearing mice. In this biodistribution study, CLR 1602, a paclitaxel Cremophor EL-free formulation (formulated without Cremophor, which is believed to contribute to free paclitaxel adverse event profile), was compared to free paclitaxel at equivalent sub-therapeutic concentrations in an effort to demonstrate enhanced CLR 1602 tumor targeting vs. free paclitaxel.

“This promising new in vivo paclitaxel data further confirms the tumor targeting selectivity of our PDC carrier, which has been consistently observed with oncology therapeutics and imaging agents. With targeting confirmed, we will now optimize the PDC linker with the aim of enhancing the cytotoxic impact on cancer cells,” said Jamey Weichert, PhD, founder and Chief Scientific Officer of Cellectar Biosciences. “Furthermore, these results validate our ‘tool kit’ concept whereby carbon-14 labeled versions of our PDCs are utilized to quickly assess the potential tumor targeting enhancement that our PDC delivery system may afford to existing or new chemotherapeutic agents.”

These quantitative results comparing biodistribution of CLR 1602 vs. free paclitaxel will be the subject of a poster presented at the 35th National Medicinal Chemistry Symposium in Chicago, June 26-29. The company also anticipates further data to be presented at another conference later this year.

Cellectar Biosciences is developing phospholipid drug conjugates (PDCs) designed to provide cancer-targeted delivery of diverse oncologic payloads to a broad range of cancers and cancer stem cells. Cellectar’s PDC Delivery Platform is based on the company’s proprietary phospholipid ether analogs. These novel small molecules have demonstrated highly selective uptake and retention in a broad range of cancers. Cellectar’s PDC pipeline includes product candidates for cancer therapy and cancer diagnostic imaging. The company’s lead therapeutic PDC, CLR 131, utilizes iodine-131, a cytotoxic radioisotope, as its payload. CLR 131 is currently being evaluated under an orphan drug designated Phase I study in patients with relapsed or refractory multiple myeloma. The company is actively developing PDCs for targeted delivery of chemotherapeutics, such as paclitaxel (CLR 1602-PTX), a preclinical-stage product candidate, and plans to expand its PDC chemotherapeutic pipeline through both in-house and collaborative R&D efforts. For more information, visit www.cellectarbiosciences.com.