- Roche has withdrawn its notification to U.S. regulators of the proposed $4.8 billion acquisition of Spark Therapeutics because additional antitrust review is necessary. Both companies have developed therapies to treat hemophilia, a space that is likely to see intense competition should Spark's SPK-8011 successfully launch.
- Switzerland-based Roche has extended its tender offer to Spark shareholders, with the deadline now set for June 3. This is the second time the tender has been extended, as issues surrounding antitrust review and shareholder lawsuits triggered a delay earlier in April.
- Roche is eager to close the transaction with Spark, which became the first company to achieve approval of a gene therapy in the U.S. with Luxturna, a treatment for an inherited form of blindness. Experimental gene therapies for hemophilia A and B should complement Roche's in-house Hemlibra, which had sales of 219 million francs, or $214 million, in the first quarter of 2019.
This is not how an acquisition usually goes for Roche. Withdrawing and refiling government paperwork, and consequently being forced to extend the deadline for selling shares, is probably not what it expected.
Crosstown rival Novartis, meanwhile, pulled off with relative ease its $8.7 billion takeout of another gene therapy player, AveXis, last year.
Roche announced that because U.S. antitrust regulators need additional time for review of the transaction, it must withdraw its Premerger Notification and Report Form, which it plans to refile on May 9. Under U.S. law, that filing date would set a deadline of May 24 for the government to object, and expiration of the review period would allow it to proceed.
A Roche spokesman would not clarify the issues under review.
Having potentially three of the newest hemophilia treatments in the hands of a single seller is a possible point of contention. Although, with BioMarin Pharmaceutical and Pfizer developing rival hemophilia A products to SPK-8011, there is likely to be competition. Roche's Hemlibra treats hemophilia A, but is a monoclonal antibody that must be infused no less than once a month. Gene therapies like Spark's and BioMarin's, by contrast, are in theory a one-time treatment.
In hemophilia B, Spark has partnered another gene therapy, fidanacogene elaparvovec, with Pfizer, so there may need to be some analysis of the market to see if the two big pharmas would have too much market power. In this condition, UniQure is hoping to make a splash.
Another area that could raise regulator concerns is Spark's manufacturing capacity, which it built to meet commercial demand for Luxturna and pipeline products. Manufacturing capacity has been a concern as gene therapies have neared the market. In response, biotechs and contract manufacturers alike have rushed to expand.
If regulators have no objection to the acquisition, Roche will have until June 3 to buy half of Spark's shares and complete the transaction. The previous extension was set to run out on May 2.